Pixel array medical devices and methods

ABSTRACT

Systems, instruments, and methods are described in which an apparatus comprises a housing including a scalpet device. The scalpet device includes a scalpet array that includes scalpets arranged in a pattern. The scalpets are deployable from the housing to generate incised skin pixels at a target site. The housing is positioned and the scalpet array is deployed into tissue at the target site. Incised skin pixels are generated when the target site is a donor site, and skin defects are generated when the target site is a recipient site. The incised skin pixels are harvested.

RELATED APPLICATIONS

This application claims the benefit of U.S. Patent Application No.62/044,060, filed Aug. 29, 2014.

This application claims the benefit of U.S. Patent Application No.62/044,078, filed Aug. 29, 2014.

This application claims the benefit of U.S. Patent Application No.62/044,089, filed Aug. 29, 2014.

This application claims the benefit of U.S. Patent Application No.62/044,102, filed Aug. 29, 2014.

This application is a continuation in part of U.S. patent applicationSer. No. 14/099,380, filed Dec. 6, 2013, which claims the benefit ofU.S. Patent Application No. 61/734,313, filed Dec. 6, 2012.

This application is a continuation in part of U.S. patent applicationSer. No. 12/972,013, filed Dec. 17, 2010, which claims the benefit ofU.S. Patent Application No. 61/288,141, filed Dec. 18, 2009.

This application is a continuation in part of U.S. patent applicationSer. No. 14/505,090, filed Oct. 2, 2014.

TECHNICAL FIELD

The embodiments herein relate to medical systems, instruments ordevices, and methods and, more particularly, to medical instrumentationand methods applied to the surgical management of burns, skin defects,and hair transplantation.

BACKGROUND

The aging process is most visibly depicted by the development ofdependent skin laxity. This life long process may become evident asearly as the third decade of life and will progressively worsen oversubsequent decades. Histological research has shown that dependantstretching or age related laxity of the skin is due in part toprogressive dermal atrophy associated with a reduction of skin tensilestrength. When combined with the downward force of gravity, age relateddermal atrophy will result in the two dimensional expansion of the skinenvelope. The clinical manifestation of this physical-histologicalprocess is redundant skin laxity. The most affected areas are the headand neck, upper arms, thighs, breasts, lower abdomen and knee regions.The most visible of all areas are the head and neck. In this region,prominent “turkey gobbler” laxity of neck and “jowls” of the lower faceare due to an unaesthetic dependency of skin in these areas.

Plastic surgery procedures have been developed to resect the redundantlax skin. These procedures must employ long incisions that are typicallyhidden around anatomical boundaries such as the ear and scalp for afacelift and the inframammary fold for a breast uplift (mastopexy).However, some areas of skin laxity resection are a poor tradeoff betweenthe aesthetic enhancement of tighter skin and the visibility of thesurgical incision. For this reason, skin redundancies of the upper arm,suprapatellar knees, thighs and buttocks are not routinely resected dueto the visibility of the surgical scar.

The frequency and negative societal impact of this aesthetic deformityhas prompted the development of the “Face Lift” surgical procedure.Other related plastic surgical procedures in different regions are theAbdominoplasty (Abdomen), the Mastopexy (Breasts), and the Brachioplasty(Upper Arms). Inherent adverse features of these surgical procedures arepost-operative pain, scarring and the risk of surgical complications.Even though the aesthetic enhancement of these procedures is anacceptable tradeoff to the significant surgical incisions required,extensive permanent scarring is always an incumbent part of theseprocedures. For this reason, plastic surgeons design these procedures tohide the extensive scarring around anatomical borders such as thehairline (Facelift), the inframmary fold (Mastopexy), and the inguinalcrease (Abdominoplasty). However, many of these incisions are hiddendistant to the region of skin laxity, thereby limiting theireffectiveness. Other skin laxity regions such as the Suprapatellar(upper-front) knee are not amendable to plastic surgical resections dueto the poor tradeoff with a more visible surgical scar.

More recently, electromagnetic medical devices that create a reversethermal gradient (i.e., Thermage) have attempted with variable successto tighten skin without surgery. At this time, these electromagneticdevices are best deployed in patients with a moderate amount of skinlaxity. Because of the limitations of electromagnetic devices andpotential side effects of surgery, a minimally invasive technology isneeded to circumvent surgically related scarring and the clinicalvariability of electromagnetic heating of the skin. For many patientswho have age related skin laxity (neck and face, arms, axillas, thighs,knees, buttocks, abdomen, bra line, ptosis of the breast), fractionalresection of excess skin could augment a significant segment oftraditional plastic surgery.

Even more significant than aesthetic modification of the skin envelopeis the surgical management of burns and other trauma related skindefects. Significant burns are classified by the total body surfaceburned and by the depth of thermal destruction. First-degree andsecond-degree burns are generally managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin. The surgical management of these serious injuries involves thedebridement of the burn eschar and the application of split thicknessgrafts.

Any full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using current commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts, that is,from the same patient. Typically, the donor site on the burn patient ischosen in a non-burned area and a partial thickness sheet of skin isharvested from that area. Incumbent upon this procedure is the creationof a partial thickness skin defect at the donor site. This donor sitedefect is itself similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity is createdthat is permanently thinner and more de-pigmented than the surroundingskin. For patients who have burns over a significant surface area, theextensive harvesting of skin grafts may also be limited by theavailability of non-burned areas.

For these reasons, there is a need in the rapidly expanding aestheticmarket for instrumentation and procedures for aesthetic surgical skintightening. There is also a need for systems, instruments or devices,and procedures that enable the repeated harvesting of skin grafts fromthe same donor site while eliminating donor site deformity.

INCORPORATION BY REFERENCE

Each patent, patent application, and/or publication mentioned in thisspecification is herein incorporated by reference in its entirety to thesame extent as if each individual patent, patent application, and/orpublication was specifically and individually indicated to beincorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows the PAD Kit placed at a target site, under an embodiment.

FIG. 2 is a cross-section of a scalpet punch or device including ascalpet array, under an embodiment.

FIG. 3 is a partial cross-section of a scalpet punch or device includinga scalpet array, under an embodiment.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment.

FIG. 6 shows the removal of skin pixels, under an embodiment.

FIG. 7 is a side view of blade transection and removal of incised skinpixels with the PAD Kit, under an embodiment.

FIG. 8 is an isometric view of blade/pixel interaction during aprocedure using the PAD Kit, under an embodiment.

FIG. 9 is another view during a procedure using the PAD Kit (bladeremoved for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment.

FIG. 10A is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an embodiment.

FIG. 10B is a side view of a portion of the pixel array showing scalpetssecured onto an investing plate, under an alternative embodiment.

FIG. 10C is a top view of the scalpet plate, under an embodiment.

FIG. 10D is a close view of a portion of the scalpet plate, under anembodiment.

FIG. 11A shows an example of rolling pixel drum, under an embodiment.

FIG. 11B shows an example of a rolling pixel drum assembled on a handle,under an embodiment.

FIG. 11C depicts a drum dermatome for use with the scalpet plate, underan embodiment.

FIG. 12A shows the drum dermatome positioned over the scalpet plate,under an embodiment.

FIG. 12B is an alternative view of the drum dermatome positioned overthe scalpet plate, under an embodiment.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment.

FIG. 13B is a side view of a portion of the drum dermatome showing ablade position relative to the scalpet plate, under an embodiment.

FIG. 13C is a side view of the portion of the drum dermatome showing adifferent blade position relative to the scalpet plate, under anembodiment.

FIG. 13D is a side view of the drum dermatome with another bladeposition relative to the scalpet plate, under an embodiment.

FIG. 13E is a side view of the drum dermatome with the transection bladeclip showing transection of skin pixels by the blade clip, under anembodiment.

FIG. 13F is a bottom view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 13H is a back view of the drum dermatome along with the scalpetplate, under an embodiment.

FIG. 14A shows an assembled view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14B is an exploded view of the dermatome with the Pixel OnlaySleeve (POS), under an embodiment.

FIG. 14C shows a portion of the dermatome with the Pixel Onlay Sleeve(POS), under an embodiment.

FIG. 15A shows the Slip-On PAD being slid onto a Padgett Drum Dermatome,under an embodiment.

FIG. 15B shows an assembled view of the Slip-On PAD installed over thePadgett Drum Dermatome, under an embodiment.

FIG. 16A shows the Slip-On PAD installed over a Padgett Drum Dermatomeand used with a perforated template or guide plate, under an embodiment.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment.

FIG. 17B shows an alternative view of a portion of the Pixel DrumDermatome being applied to a target site of the skin surface, under anembodiment.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment.

FIG. 19B shows a bottom perspective view of the scalpet device for usewith the PAD assembly, under an embodiment.

FIG. 20 shows a side view of the punch impact device including a vacuumcomponent, under an embodiment.

FIG. 21A shows a top view of an oscillating flat scalpet array and bladedevice, under an embodiment.

FIG. 21B shows a bottom view of an oscillating flat scalpet array andblade device, under an embodiment.

FIG. 21C is a close-up view of the flat array when the array ofscalpets, blades, adherent membrane and the adhesive backer areassembled together, under an embodiment.

FIG. 21D is a close-up view of the flat array of scalpets with a feedercomponent, under an embodiment.

FIG. 22 shows a cadaver dermal matrix cylindrically transected similarin size to the harvested skin pixel grafts, under an embodiment.

FIG. 23 is a drum array drug delivery device, under an embodiment.

FIG. 24A is a side view of a needle array drug delivery device, under anembodiment.

FIG. 24B is an upper isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 24C is a lower isometric view of a needle array drug deliverydevice, under an embodiment.

FIG. 25 shows the composition of human skin.

FIG. 26 shows the physiological cycles of hair growth.

FIG. 27 shows harvesting of donor follicles, under an embodiment.

FIG. 28 shows preparation of the recipient site, under an embodiment.

FIG. 29 shows placement of the harvested hair plugs at the recipientsite, under an embodiment.

FIG. 30 shows placement of the perforated plate on the occipital scalpdonor site, under an embodiment.

FIG. 31 shows scalpet penetration depth through skin when the scalpet isconfigured to penetrate to the subcutaneous fat layer to capture thehair follicle, under an embodiment.

FIG. 32 shows hair plug harvesting using the perforated plate at theoccipital donor site, under an embodiment.

FIG. 33 shows creation of the visible hairline, under an embodiment.

FIG. 34 shows preparation of the donor site using the patternedperforated plate and spring-loaded pixilation device to create identicalskin defects at the recipient site, under an embodiment.

FIG. 35 shows transplantation of harvested plugs by inserting harvestedplugs into a corresponding skin defect created at the recipient site,under an embodiment.

FIG. 36 shows a clinical end point using the pixel dermatomeinstrumentation and procedure, under an embodiment.

FIG. 37 is an image of the skin tattooed at the corners and midpoints ofthe area to be resected, under an embodiment.

FIG. 38 is an image of the post-operative skin resection field, under anembodiment.

FIG. 39 is an image at 11 days following the procedure showingresections healed per primam, with measured margins, under anembodiment.

FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment.

FIG. 41 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured lateral dimensions, under anembodiment.

FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

DETAILED DESCRIPTION

Embodiments described herein satisfy the expanding aesthetic market forinstrumentation and procedures for aesthetic surgical skin tightening.Additionally, the embodiment enable the repeated harvesting of skingrafts from the same donor site while eliminating donor site deformity.The embodiments described herein are configured to resect redundant laxskin without visible scarring so that all areas of redundant skin laxitycan be resected by the pixel array dermatome and procedures may beperformed in areas that were previously off limits due to the visibilityof the surgical incision. The technical effects realized through theembodiments described herein include smooth, tightened skin withoutvisible scarring or long scars along anatomical borders.

Embodiments described in detail herein, which include pixel skingrafting instrumentation and methods, are configured to provide thecapability to repeatedly harvest split thickness skin grafts withoutvisible scarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) is used to harvest the skin graft from the chosen donorsite. During the harvesting procedure, a pixilated skin graft isdeposited onto a flexible, semi-porous, adherent membrane. The harvestedskin graft/membrane composite is then applied directly to the recipientskin defect site. The fractionally resected donor site is closed withthe application of an adherent sheeting or bandage (e.g., Flexzan®sheeting, etc.) that functions for a period of time (e.g., one week,etc.) as a large butterfly bandage. The intradermal skin defectsgenerated by the PAD are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring postoperatively,the adherent membrane is desquamated (shed) with the stratum corneum ofthe graft; the membrane can then be removed without disruption of thegraft from the recipient bed.

Numerous effects realized by the pixel skin grafting procedure deserveexplanation. Because the skin graft is pixelated it provides intersticesfor drainage between skin plug components, which enhances the percentageof “takes,” compared to sheet skin grafts. During the firstpost-operative week, the skin graft “takes” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semiporousmembrane conducts the exudate into the dressing.

The flexible membrane is configured with an elastic recoil property thatpromotes apposition of component skin plugs within the graft/membranecomposite; promoting primary adjacent healing of the skin graft plugsand converting the pixilated appearance of the skin graft into a moreuniform sheet morphology. Furthermore, the membrane aligns themicro-architectural components skin plugs, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring.

There are numerous major clinical applications for the dermatomesdescribed in detail herein, including fractional skin resection for skintightening, fractional hair grafting for alopecia, and fractional skinharvesting for skin grafting. Fractional skin resection of an embodimentcomprises harvesting skin plugs using an adherent membrane, however thefractionally incised skin plugs can be evacuated without harvesting. Theparadigm of incising, evacuating and closing is most descriptive of theclinical application of skin tightening. The embodiments describedherein are configured to facilitate incising and evacuating and, inorder to provide for a larger scalpet array with a greater number ofscalpets, the embodiments include a novel means of incising the skinsurface.

Pixel array medical systems, instruments or devices, and methods aredescribed for skin grafting and skin resection procedures, and hairtransplantation procedures. In the following description, numerousspecific details are introduced to provide a thorough understanding of,and enabling description for, embodiments herein. One skilled in therelevant art, however, will recognize that these embodiments can bepracticed without one or more of the specific details, or with othercomponents, systems, etc. In other instances, well-known structures oroperations are not shown, or are not described in detail, to avoidobscuring aspects of the disclosed embodiments.

The following terms are intended to have the following general meaningas they may be used herein. The terms are not however limited to themeanings stated herein as the meanings of any term can include othermeanings as understood or applied by one skilled in the art.

“First degree burn” as used herein includes a superficial thermal injuryin which there is no disruption of the epidermis from the dermis. Afirst-degree burn is visualized as erythema (redness) of the skin.

“Second degree burn” as used herein includes a relatively deeper burn inwhich there is disruption of the epidermis from the dermis and where avariable thickness of the dermis is also denatured. Most second-degreeburns are associated with blister formation. Deep second-degree burnsmay convert to full thickness third degree burns, usually by oxidationor infection.

“Third degree burn” as used herein includes a burn associated with thefull thickness thermal destruction of the skin including the epidermisand the dermis. A third degree burn may also be associated with thermaldestruction of deeper, underlying tissues (subcutaneous and musclelayers).

“Ablation” as used herein includes the removal of tissue by destructionof the tissue e.g., thermal ablation of a skin lesion by a laser.

“Autograft” as used herein includes a graft taken from the same patient.

“Backed Adherent Membrane” as used herein includes the elastic adherentmembrane that captures the transected skin plugs. The Backed AdherentMembrane of an embodiment is backed on the outer surface to retainalignment of the skin plugs during harvest. After harvesting of the skinplugs, the backing is removed from the adherent membrane with harvestedskin plugs. The membrane of an embodiment is porous to allow fordrainage when placed at the recipient site. The membrane of anembodiment also possesses an elastic recoil property, so that when thebacking is removed, it brings the sides of the skin plugs closer to eachother to promote healing at the recipient site as a sheet graft.

“Burn Scar Contraction” as used herein includes the tightening of scartissue that occurs during the wound healing process. This process ismore likely to occur with an untreated third degree burn.

“Burn Scar Contracture” as used herein includes a band of scar tissuethat either limits the range of motion of a joint or band of scar tissuethat distorts the appearance of the patient i.e., a burn scarcontracture of the face.

“Dermatome” as used herein includes an instrument that “cuts skin” orharvests a sheet split thickness skin graft. Examples of drum dermatomesinclude the Padgett and Reese dermatomes. Electrically powereddermatomes are the Zimmer dermatome and one electric version of thePadgett dermatome.

“Dermis” as used herein includes the deep layer of skin that is the mainstructural support and primarily comprises non-cellular collagen fibers.Fibroblasts are cells in the dermis that produce the collagen proteinfibers.

“Donor Site” as used herein includes the anatomical site from which askin graft is harvested.

“Epidermis” as used herein includes the outer layer of skin comprisingviable epidermal cells and nonviable stratum corneum that acts as abiological barrier.

“Excise” as used herein includes the surgical removal of tissue.

“Excisional Skin Defect” as used herein includes a partial thickness or,more typically, a full thickness defect that results from the surgicalremoval (excision/resection) of skin (lesion).

“FTSG” as used herein includes a Full Thickness Skin Graft in which theentire thickness of the skin is harvested. With the exception of aninstrument as described herein, the donor site is closed as a surgicalincision. For this reason, FTSG is limited in the surface area that canbe harvested.

“Granulation Tissue” as used herein includes highly vascularized tissuethat grows in response to the absence of skin in a full-thickness skindefect. Granulation Tissue is the ideal base for a skin graft recipientsite.

“Healing by primary intention” as used herein includes the wound healingprocess in which normal anatomical structures are realigned with aminimum of scar tissue formation. Morphologically the scar is lesslikely to be visible.

“Healing by secondary intention” as used herein includes a lessorganized wound healing process wherein healing occurs with lessalignment of normal anatomical structures and with an increaseddeposition of scar collagen. Morphologically, the scar is more likely tobe visible.

“Homograft” as used herein includes a graft taken from a different humanand applied as a temporary biological dressing to a recipient site on apatient. Most homografts are harvested as cadaver skin. A temporary“take” of a homograft can be partially achieved with immunosuppressionbut homografts are eventually replaced by autografts if the patientsurvives.

“Incise” as used herein includes the making of a surgical incisionwithout removal of tissue.

“Mesh Split Thickness Skin Graft” as used herein includes a splitthickness skin graft that is expanded in its surface area byrepetitiously incising the harvested skin graft with an instrumentcalled a “mesher”. A meshed split thickness skin graft has a higherpercentage of “take” than a sheet graft because it allows drainagethrough the graft and conforms better to the contour irregularities ofthe recipient site. However, it does result in an unsightly reticulatedappearance of the graft at the recipient site.

“PAD” as used herein includes a Pixel Array Dermatome, the class ofinstruments for fractional skin resection.

“PAD Kit” as used herein includes the disposable single use procedurekit comprising the perforated guide plate, scalpet stamper, the guideplate frame, the backed adherent membrane and the transection blade.

“Perforated Guide Plate” as used herein includes a perforated platecomprising the entire graft harvest area in which the holes of the guideplate are aligned with the scalpets of the handled stamper or theSlip-on PAD. The plate will also function as a guard to preventinadvertent laceration of the adjacent skin. The perforations of theGuide Plate can be different geometries such as, but not limited to,round, oval, square, rectangular, and/or triangular.

“Pixelated Full Thickness Skin Graft” as used herein includes a FullThickness Skin Graft that has been harvested with an instrument asdescribed herein without reduced visibly apparent scarring at the donorsite. The graft will also possess an enhanced appearance at therecipient site similar to a sheet FTSG but will conform better torecipient site and will have a higher percentage of ‘take’ due todrainage interstices between skin plugs. Another significant advantageof the pixelated FTSG in comparison to a sheet FTSG is the ability tograft larger surface areas that would otherwise require a STSG. Thisadvantage is due to the capability to harvest from multiple donor siteswith reduced visible scarring.

“Pixelated Graft Harvest” as used herein includes the skin graftharvesting from a donor site by an instrument as described in detailherein.

“Pixelated Spilt Thickness Skin Graft” as used herein includes a partialthickness skin graft that has been harvested with an SRG instrument. Theskin graft shares the advantages of a meshed skin graft withoutunsightly donor and recipient sites.

“Recipient Site” as used herein includes the skin defect site where askin graft is applied.

“Resect” as used herein includes excising.

“Scalpel” as used herein includes the single-edged knife that incisesskin and soft tissue.

“Scalpet” as used herein includes the term that describes the smallgeometrically-shaped (e.g., circle, ellipse, rectangle, square, etc.)scalpel that incises a plug of skin.

“Scalpet Array” as used herein includes the arrangement or array ofmultiple scalpets secured to a substrate (e.g., a base plate, stamper,handled stamper, tip, disposable tip, etc.).

“Scalpet Stamper” as used herein includes a handled scalpet arrayinstrument component of the PAD Kit that incises skin plugs through theperforated guide plate.

“Scar” as used herein includes the histological deposition ofdisorganized collagen following wounding, or the morphological deformitythat is visually apparent from the histological deposition ofdisorganized collagen following wounding.

“Sheet Full Thickness Skin Graft” as used herein includes reference toapplication of the FTSG at the recipient site as continuous sheet. Theappearance of an FTSG is superior to the appearance of a STSG and forthis reason it is primarily used for skin grafting in visually apparentareas such as the face.

“Sheet Split Thickness Skin Graft” as used herein includes a partialthickness skin graft that is a continuous sheet and is associated withthe typical donor site deformity.

“Skin Defect” as used herein includes the absence of the full thicknessof skin that may also include the subcutaneous fat layer and deeperstructures such as muscle. Skin defects can occur from a variety ofcauses i.e., burns, trauma, surgical excision of malignancies and thecorrection of congenital deformities.

“Skin Pixel” as used herein includes a piece of skin comprisingepidermis and a partial or full thickness of the dermis that is cut bythe scalpet; the skin pixel may include skin adnexa such as a hairfollicle with or without a cuff of subcutaneous fat; also includes SkinPlug.

“Skin Plug” as used herein includes a circular (or other geometricshaped) piece of skin comprising epidermis and a partial or fullthickness of the dermis that is incised by the scalpet, transected bythe transection blade and captured by the adherent-backed membrane.

“STSG” as used herein includes the Partial Thickness Skin Graft in whichthe epidermis and a portion of the dermis is harvested with the graft.

“Subcutaneous Fat Layer” as used herein includes the layer that isimmediately below the skin and is principally comprised of fat cellsreferred to as lipocytes. This layer functions as principle insulationlayer from the environment.

“Transection Blade” as used herein includes a horizontally-alignedsingle edged blade that can be either slotted to the frame of theperforated plate or attached to the outrigger arm of the drum dermatomeas described in detail herein. The transection blade transects the baseof the incised skin plugs.

“Wound Healing” as used herein includes the obligate biological processthat occurs from any type of wounding whether it be one or more ofthermal, kinetic and surgical.

“Xenograft” as used herein includes a graft taken from a differentspecies and applied as a temporary biological dressing to a recipientsite on a patient.

Multiple embodiments of pixel array medical systems, instruments ordevices, and methods for use are described in detail herein. Thesystems, instruments or devices, and methods described herein compriseminimally invasive surgical approaches for skin grafting and for skinresection that tightens lax skin without visible scarring via a deviceused in various surgical procedures such as plastic surgery procedures,and additionally for hair transplantation. In some embodiments, thedevice is a single use disposable instrument. The embodiments hereincircumvent surgically related scarring and the clinical variability ofelectromagnetic heating of the skin and perform small multiple pixilatedresections of skin as a minimally invasive alternative to large plasticsurgical resections of skin. The embodiments herein can also be employedin hair transplantation, and in areas of the body that may be off limitsto plastic surgery due to the visibility of the surgical scar. Inaddition, the approach can perform a skin grafting operation byharvesting the transected incisions of skin from a tissue site of adonor onto a skin defect site of a recipient with reduced scarring ofthe patient's donor site.

For many patients who have age related skin laxity (for non-limitingexamples, neck and face, arms, axillas, thighs, knees, buttocks,abdomen, bra line, ptosis of the breast, etc.), the minimally invasivepixel array medical devices and methods herein perform pixilatedtransection/resection of excess skin, replacing plastic surgery with itsincumbent scarring. Generally, the procedures described herein areperformed in an office setting under a local anesthetic with minimalperioperative discomfort, but are not so limited. In comparison to aprolonged healing phase from plastic surgery, only a short recoveryperiod is required, preferably applying a dressing and a support garmentworn over the treatment area for a pre-specified period of time (e.g., 5days, 7 days, etc.). There will be minimal or no pain associated withthe procedure.

The relatively small (e.g., in a range of approximately 0.5 mm to 4.0mm) skin defects generated by the instrumentation described herein areclosed with the application of an adherent Flexan® sheet. Functioning asa large butterfly bandage, the Flexan® sheet can be pulled in adirection (“vector”) that maximizes the aesthetic contouring of thetreatment area. A compressive elastic garment is applied over thedressing to further assist aesthetic contouring. After completion of theinitial healing phase, the multiplicity of small linear scars within thetreatment area will have reduced visibility in comparison to largerplastic surgical incisions on the same area. Additional skin tighteningis likely to occur over several months due to the delayed wound healingresponse. Other potential applications of the embodiments describedherein include hair transplantation as well as the treatment ofAlopecia, Snoring/Sleep apnea, Orthopedics/Physiatry, VaginalTightening, Female Urinary incontinence, and tightening ofgastrointestinal sphincters.

Significant burns are classified by the total body surface burned and bythe depth of thermal destruction, and the methods used to manage theseburns depend largely on the classification. First-degree andsecond-degree burns are usually managed in a non-surgical fashion withthe application of topical creams and burn dressings. Deeperthird-degree burns involve the full thickness thermal destruction of theskin, creating a full thickness skin defect. The surgical management ofthis serious injury usually involves the debridement of the burn escharand the application of split thickness grafts.

A full thickness skin defect, most frequently created from burning,trauma, or the resection of a skin malignancy, can be closed with eitherskin flap transfers or skin grafts using conventional commercialinstrumentation. Both surgical approaches require harvesting from adonor site. The use of a skin flap is further limited by the need of toinclude a pedicle blood supply and in most cases by the need to directlyclose the donor site.

The split thickness skin graft procedure, due to immunologicalconstraints, requires the harvesting of autologous skin grafts from thesame patient. Typically, the donor site on the burn patient is chosen ina non-burned area and a partial thickness sheet of skin is harvestedfrom that area. Incumbent upon this procedure is the creation of apartial thickness skin defect at the donor site. This donor site defectitself is similar to a deep second-degree burn. Healing byre-epithelialization of this site is often painful and may be prolongedfor several days. In addition, a visible donor site deformity istypically created that is permanently thinner and more de-pigmented thanthe surrounding skin. For patients who have burns over a significantsurface area, the extensive harvesting of skin grafts may also belimited by the availability of non-burned areas.

Both conventional surgical approaches to close skin defects (flaptransfer and skin grafting) are not only associated with significantscarring of the skin defect recipient site but also with the donor sitefrom which the graft is harvested. In contrast to the conventionalprocedures, embodiments described herein comprise Pixel Skin GraftingProcedures, also referred to as a pixel array procedures, that eliminatethis donor site deformity and provide a method to re-harvest skin graftsfrom any pre-existing donor site including either sheet or pixelateddonor sites. This ability to re-harvest skin grafts from pre-existingdonor sites will reduce the surface area requirement for donor site skinand provide additional skin grafting capability in severely burnedpatients who have limited surface area of unburned donor skin.

The Pixel Skin Grafting Procedure of an embodiment is used as a fullthickness skin graft. Many clinical applications such as facial skingrafting, hand surgery, and the repair of congenital deformities arebest performed with full thickness skin grafts. The texture,pigmentation and overall morphology of a full thickness skin graft moreclosely resembles the skin adjacent to a defect than a split thicknessskin graft. For this reason, full thickness skin grafting in visiblyapparent areas is superior in appearance than split thickness skingrafts. The main drawback to full thickness skin grafts underconventional procedures is the extensive linear scarring created fromthe surgical closure of the full thickness donor site defect; thisscarring limits the size and utility of full thickness skin grafting.

In comparison, the full thickness skin grafting of the Pixel SkinGrafting Procedure described herein is less limited by size and utilityas the linear donor site scar is eliminated. Thus, many skin defectsroutinely covered with split thickness skin grafts will instead betreated using pixelated full thickness skin grafts.

The Pixel Skin Grafting Procedure provides the capability to harvestsplit thickness and full thickness skin grafts with minimal visiblescarring of the donor site. During the procedure, a Pixel ArrayDermatome (PAD) device is used to harvest the skin graft from a chosendonor site. During the harvesting procedure, the pixilated skin graft isdeposited onto an adherent membrane. The adherent membrane of anembodiment includes a flexible, semi-porous, adherent membrane, but theembodiment is not so limited. The harvested skin graft/membranecomposite is then applied directly to the recipient skin defect site.The fractionally resected donor site is closed with the application ofan adherent Flexan® sheeting that functions for one week as a largebutterfly bandage. The relatively small (e.g., 1.5 mm) intradermalcircular skin defects are closed to promote a primary healing process inwhich the normal epidermal-dermal architecture is realigned in ananatomical fashion to minimize scarring. Also occurring approximatelyone week postoperatively, the adherent membrane is desquamated (shed)with the stratum corneum of the graft; the membrane can then be removedwithout disruption of the graft from the recipient bed. Thus, healing ofthe donor site occurs rapidly with minimal discomfort and scarring.

Because the skin graft at the recipient defect site using the Pixel SkinGrafting Procedure is pixelated it provides interstices for drainagebetween skin pixel components, which enhances the percentage of “takes,”compared to sheet skin grafts. During the first post-operative week(approximate), the skin graft will “take” at the recipient site by aprocess of neovascularization in which new vessels from the recipientbed of the skin defect grow into the new skin graft. The semi-porousmembrane will conduct the transudate (fluid) into the dressing.Furthermore, the flexible membrane is designed with an elastic recoilproperty that promotes apposition of component skin pixels within thegraft/membrane composite and promotes primary adjacent healing of theskin graft pixels, converting the pixilated appearance of the skin graftto a uniform sheet morphology. Additionally, the membrane aligns themicro-architectural component skin pixels, so epidermis aligns withepidermis and dermis aligns with dermis, promoting a primary healingprocess that reduces scarring. Moreover, pixelated skin grafts moreeasily conform to an irregular recipient site.

Embodiments described herein also include a Pixel Skin ResectionProcedure, also referred to herein as the Pixel Procedure. For manypatients who have age related skin laxity (neck and face, arms, axillas,thighs, knees, buttocks, abdomen, bra line, ptosis of the breast, etc.),fractional resection of excess skin could replace a significant segmentof plastic surgery with its incumbent scarring. Generally, the PixelProcedure will be performed in an office setting under a localanesthetic. The post procedure recovery period includes wearing of asupport garment over the treatment area for a pre-specified number(e.g., five, seven, etc.) of days (e.g., five days, seven days, etc.).Relatively little or no pain is anticipated to be associated with theprocedure. The small (e.g., 1.5 mm) circular skin defects will be closedwith the application of an adherent Flexan® sheet. Functioning as alarge butterfly bandage, the Flexan® sheet is pulled in a direction(“vector”) that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing tofurther assist aesthetic contouring. After completion of the initialhealing phase, the multiplicity of small linear scars within thetreatment area will not be visibly apparent. Furthermore, additionalskin tightening will subsequently occur over several months due to thedelayed wound healing response. Consequently, the Pixel Procedure is aminimally invasive alternative to the extensive scarring of PlasticSurgery.

The pixel array medical devices of an embodiment include a PAD Kit. FIG.1 shows the PAD Kit placed at a target site, under an embodiment. ThePAD Kit comprises a flat perforated guide plate (guide plate), a scalpetpunch or device that includes a scalpet array (FIGS. 1-3), a backedadhesive membrane or adherent substrate (FIG. 4), and a skin pixeltransection blade (FIG. 5), but is not so limited. The scalpet punch ofan embodiment is a handheld device but is not so limited. The guideplate is optional in an alternative embodiment, as described in detailherein.

FIG. 2 is a cross-section of a PAD Kit scalpet punch including a scalpetarray, under an embodiment. The scalpet array includes one or morescalpets. FIG. 3 is a partial cross-section of a PAD Kit scalpet punchincluding a scalpet array, under an embodiment. The partialcross-section shows the total length of the scalpets of the scalpetarray is determined by the thickness of the perforated guide plate andthe incisional depth into the skin, but the embodiment is not solimited.

FIG. 4 shows the adhesive membrane with backing (adherent substrate)included in a PAD Kit, under an embodiment. The undersurface of theadhesive membrane is applied to the incised skin at the target site.

FIG. 5 shows the adhesive membrane (adherent substrate) when used withthe PAD Kit frame and blade assembly, under an embodiment. The topsurface of the adhesive membrane is oriented with the adhesive side downinside the frame and then pressed over the perforated plate to capturethe extruded skin pixels, also referred to herein as plugs or skinplugs.

With reference to FIG. 1, the perforated guide plate is applied to theskin resection/donor site during a procedure using the PAD Kit. Thescalpet punch is applied through at least a set of perforations of theperforated guide plate to incise the skin pixels. The scalpet punch isapplied numerous times to a number of sets of perforations when thescalpet array of the punch includes fewer scalpets then the total numberof perforations of the guide plate. Following one or more serialapplications with the scalpet punch, the incised skin pixels or plugsare captured onto the adherent substrate. The adherent substrate is thenapplied in a manner so the adhesive captures the extruded skin pixels orplugs. As an example, the top surface of the adherent substrate of anembodiment is oriented with the adhesive side down inside the frame(when the frame is used) and then pressed over the perforated plate tocapture the extruded skin pixels or plugs. As the membrane is pulled up,the captured skin pixels are transected at their base by the transectionblade.

FIG. 6 shows the removal of skin pixels, under an embodiment. Theadherent substrate is pulled up and back (away) from the target site,and this act lifts or pulls the incised skin pixels or plugs. As theadherent substrate is being pulled up, the transection blade is used totransect the bases of the incised skin pixels. FIG. 7 is a side view ofblade transection and removal of incised skin pixels with the PAD Kit,under an embodiment. Pixel harvesting is completed with the transectionof the base of the skin pixels or plugs. FIG. 8 is an isometric view ofblade/pixel interaction during a procedure using the PAD Kit, under anembodiment. FIG. 9 is another view during a procedure using the PAD Kit(blade removed for clarity) showing both harvested skin pixels or plugstransected and captured and non-transected skin pixels or plugs prior totransection, under an embodiment. At the donor site, the pixelated skinresection sites are closed with the application of Flexan® sheeting.

The guide plate and scalpet device are also used to generate skindefects at the recipient site. The skin defects are configured toreceive the skin pixels harvested or captured at the donor site. Theguide plate used at the recipient site can be the same guide plate usedat the donor site, or can be different with a different pattern orconfiguration of perforations.

The skin pixels or plugs deposited onto the adherent substrate duringthe transection can next be transferred to the skin defect site(recipient site) where they are applied as a pixelated skin graft at arecipient skin defect site. The adherent substrate has an elastic recoilproperty that enables closer alignment of the skin pixels or plugswithin the skin graft. The incised skin pixels can be applied from theadherent substrate directly to the skin defects at the recipient site.Application of the incised skin pixels at the recipient site includesaligning the incised skin pixels with the skin defects, and insertingthe incised skin pixels into corresponding skin defects at the recipientsite.

The pixel array medical devices of an embodiment include a Pixel ArrayDermatome (PAD). The PAD comprises a flat array of relatively smallcircular scalpets that are secured onto a substrate (e.g., investingplate), and the scalpets in combination with the substrate are referredto herein as a scalpet array, pixel array, or scalpet plate. FIG. 10A isa side view of a portion of the pixel array showing scalpets securedonto an investing plate, under an embodiment. FIG. 10B is a side view ofa portion of the pixel array showing scalpets secured onto an investingplate, under an alternative embodiment. FIG. 10C is a top view of thescalpet plate, under an embodiment. FIG. 10D is a close view of aportion of the scalpet plate, under an embodiment. The scalpet plate isapplied directly to the skin surface. One or more scalpets of thescalpet array include one or more of a pointed surface, a needle, and aneedle including multiple points.

Embodiments of the pixel array medical devices and methods include useof a harvest pattern instead of the guide plate. The harvest patterncomprises indicators or markers on a skin surface on at least one of thedonor site and the recipient site, but is not so limited. The markersinclude any compound that may be applied directly to the skin to mark anarea of the skin. The harvest pattern is positioned at a donor site, andthe scalpet array of the device is aligned with or according to theharvest pattern at the donor site. The skin pixels are incised at thedonor site with the scalpet array as described herein. The recipientsite is prepared by positioning the harvest pattern at the recipientsite. The harvest pattern used at the recipient site can be the sameharvest pattern used at the donor site, or can be different with adifferent pattern or configuration of markers. The skin defects aregenerated, and the incised skin pixels are applied at the recipient siteas described herein. Alternatively, the guide plate of an embodiment isused in applying the harvest pattern, but the embodiment is not solimited.

To leverage established surgical instrumentation, the array of anembodiment is used in conjunction with or as a modification to a drumdermatome, for example a Padget dermatome or a Reese dermatome, but isnot so limited. The Padget drum dermatome referenced herein wasoriginally developed by Dr. Earl Padget in the 1930s, and continues tobe widely utilized for skin grafting by plastic surgeons throughout theworld. The Reese modification of the Padget dermatome was subsequentlydeveloped to better calibrate the thickness of the harvested skin graft.The drum dermatome of an embodiment is a single use (per procedure)disposable, but is not so limited.

Generally, FIG. 11A shows an example of a rolling pixel drum 100, underan embodiment. FIG. 11B shows an example of a rolling pixel drum 100assembled on a handle, under an embodiment. More specifically, FIG. 11Cdepicts a drum dermatome for use with the scalpet plate, under anembodiment.

Generally, as with all pixel devices described herein, the geometry ofthe pixel drum 100 can be a variety of shapes without limitation e.g.,circular, semicircular, elliptical, square, flat, or rectangular. Insome embodiments, the pixel drum 100 is supported by an axel/handleassembly 102 and rotated around a drum rotational component 104 poweredby, e.g., an electric motor. In some embodiments, the pixel drum 100 canbe placed on stand (not shown) when not in use, wherein the stand canalso function as a battery recharger for the powered rotationalcomponent of the drum or the powered component of the syringe plunger.In some embodiments, a vacuum (not shown) can be applied to the skinsurface of the pixel drum 100 and outriggers (not shown) can be deployedfor tracking and stability of the pixel drum 100.

In some embodiments, the pixel drum 100 incorporates an array ofscalpets 106 on the surface of the drum 100 to create small multiple(e.g., 0.5-1.5 mm) circular incisions referred to herein as skin plugs.In some embodiments, the border geometry of the scalpets can be designedto reduce pin cushioning (“trap door”) while creating the skin plugs.The perimeter of each skin plug can also be lengthened by the scalpetsto, for a non-limiting example, a, semicircular, elliptical, orsquare-shaped skin plug instead of a circular-shaped skin plug. In someembodiments, the length of the scalpets 106 may vary depending upon thethickness of the skin area selected by the surgeon for skin graftingpurposes, i.e., partial thickness or full thickness.

When the drum 100 is applied to a skin surface, a blade 108 placedinternal of the drum 100 transects the base of each skin plug created bythe array of scalpets, wherein the internal blade 108 is connected tothe central drum axel/handle assembly 102 and/or connected to outriggersattached to the central axel assembly 102. In some alternativeembodiments, the internal blade 108 is not connected to the drum axelassembly 102 where the base of the incisions of skin is transected. Insome embodiments, the internal blade 108 of the pixel drum 100 mayoscillate either manually or be powered by an electric motor. Dependingupon the density of the circular scalpets on the drum, a variablepercentage of skin (e.g., 20%, 30%, 40%, etc.) can be transected withinan area of excessive skin laxity.

In some embodiments, an added pixel drum harvester 112 is placed insidethe drum 100 to perform a skin grafting operation by harvesting andaligning the transected/pixilated skin incisions/plugs (pixel graft)from tissue of a pixel donor onto an adherent membrane 110 lined in theinterior of the pixel drum 100. A narrow space is created between thearray of scalpets 106 and the adherent membrane 110 for the internalblade 108.

In an embodiment, the blade 108 is placed external to the drum 100 andthe scalpet array 106 where the base of the incised circular skin plugsis transected. In another embodiment, the external blade 108 isconnected to the drum axel assembly 102 when the base of the incisionsof skin is transected. In an alternative embodiment, the external blade108 is not connected to the drum axel assembly 102 when the base of theincisions of skin is transected. The adherent membrane 110 that extractsand aligns the transected skin segments is subsequently placed over askin defect site of a patient. The blade 108 (either internal orexternal) can be a fenestrated layer of blade aligned to the scalpetarray 106, but is not so limited.

The conformable adherent membrane 110 of an embodiment can besemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned transected skin segments is extracted from thedrum and applied as a skin graft. The adherent semi-porous drum membrane110 can also have an elastic recoil property to bring thetransected/pixilated skin plugs together for grafting onto the skindefect site of the recipient, i.e., the margins of each skin plug can bebrought closer together as a more uniform sheet after the adherentmembrane with pixilated grafts extracted from the drum 100.Alternatively, the adherent semi-porous drum membrane 110 can beexpandable to cover a large surface area of the skin defect site of therecipient. In some embodiments, a sheet of adhesive backer 111 can beapplied between the adherent membrane 110 and the drum harvester 112.The drum array of scalpets 106, blade 108, and adherent membrane 110 canbe assembled together as a sleeve onto a preexisting drum 100, asdescribed in detail herein.

The internal drum harvester 112 of the pixel drum 110 of an embodimentis disposable and replaceable. Limit and/or control the use of thedisposable components can be accomplished by means that includes but isnot limited to electronic, EPROM, mechanical, durability. The electronicand/or mechanical records and/or limits of number of drum rotations forthe disposable drum as well as the time of use for the disposable drumcan be recorded, controlled and/or limited either electronically ormechanically.

During the harvesting portion of the procedure with a drum dermatome,the PAD scalpet array is applied directly to the skin surface. Tocircumferentially incise the skin pixels, the drum dermatome ispositioned over the scalpet array to apply a load onto the subjacentskin surface. With a continuing load, the incised skin pixels areextruded through the holes of the scalpet array and captured onto anadherent membrane on the drum dermatome. The cutting outrigger blade ofthe dermatome (positioned over the scalpet array) transects the base ofextruded skin pixels. The membrane and the pixelated skin composite arethen removed from the dermatome drum, to be directly applied to therecipient skin defect as a skin graft.

With reference to FIG. 11C, an embodiment includes a drum dermatome foruse with the scalpet plate, as described herein. More particularly, FIG.12A shows the drum dermatome positioned over the scalpet plate, under anembodiment. FIG. 12B is an alternative view of the drum dermatomepositioned over the scalpet plate, under an embodiment. The cuttingoutrigger blade of the drum dermatome is positioned on top of thescalpet array where the extruded skin plugs will be transected at theirbase.

FIG. 13A is an isometric view of application of the drum dermatome(e.g., Padgett dermatome) over the scalpet plate, where the adhesivemembrane is applied to the drum of the dermatome before rolling it overthe investing plate, under an embodiment. FIG. 13B is a side view of aportion of the drum dermatome showing a blade position relative to thescalpet plate, under an embodiment. FIG. 13C is a side view of theportion of the drum dermatome showing a different blade positionrelative to the scalpet plate, under an embodiment. FIG. 13D is a sideview of the drum dermatome with another blade position relative to thescalpet plate, under an embodiment. FIG. 13E is a side view of the drumdermatome with the transection blade clip showing transection of skinpixels by the blade clip, under an embodiment. FIG. 13F is a bottom viewof the drum dermatome along with the scalpet plate, under an embodiment.FIG. 13G is a front view of the drum dermatome along with the scalpetplate, under an embodiment. FIG. 13H is a back view of the drumdermatome along with the scalpet plate, under an embodiment.

Depending upon the clinical application, the disposable adherentmembrane of the drum dermatome can be used to deposit/dispose ofresected lax skin or harvest/align a pixilated skin graft.

Embodiments described herein also include a Pixel Onlay Sleeve (POS) foruse with the dermatomes, for example the Padget dermatomes and Reesedermatomes. FIG. 14A shows an assembled view of the dermatome with thePixel Onlay Sleeve (POS), under an embodiment. The POS comprises thedermatome and blade incorporated with an adhesive backer, adhesive, anda scalpet array. The adhesive backer, adhesive, and scalpet array areintegral to the device, but are not so limited. FIG. 14B is an explodedview of the dermatome with the Pixel Onlay Sleeve (POS), under anembodiment. FIG. 14C shows a portion of the dermatome with the PixelOnlay Sleeve (POS), under an embodiment.

The POS, also referred to herein as the “sleeve,” provides a disposabledrum dermatome onlay for the fractional resection of redundant lax skinand the fractional skin grafting of skin defects. The onlay sleeve isused in conjunction with either the Padget and Reese dermatomes as asingle use disposable component. The POS of an embodiment is athree-sided slip-on disposable sleeve that slips onto a drum dermatome.The device comprises an adherent membrane and a scalpet drum array withan internal transection blade. The transection blade of an embodimentincludes a single-sided cutting surface that sweeps across the internalsurface of the scalpet drum array.

In an alternative blade embodiment, a fenestrated cutting layer coversthe internal surface of the scalpet array. Each fenestration with itscutting surface is aligned with each individual scalpet. Instead ofsweeping motion to transect the base of the skin plugs, the fenestratedcutting layer oscillates over the scalpet drum array. A narrow spacebetween the adherent membrane and the scalpet array is created forexcursion of the blade. For multiple harvesting during a skin graftingprocedure, an insertion slot for additional adherent membranes isprovided. The protective layer over the adherent membrane is pealed awayinsitu with an elongated extraction tab that is pulled from anextraction slot on the opposite side of the sleeve assembly. As withother pixel device embodiments, the adherent membrane is semi-porous fordrainage at the recipient skin defect site. To morph the pixilated skingraft into a more continuous sheet, the membrane may also have anelastic recoil property to provide closer alignment of the skin plugswithin the skin graft.

Embodiments described herein include a Slip-On PAD that is configured asa single-use disposable device with either the Padgett or Reesedermatomes. FIG. 15A shows the Slip-On PAD being slid onto a PadgettDrum Dermatome, under an embodiment. FIG. 15B shows an assembled view ofthe Slip-On PAD installed over the Padgett Drum Dermatome, under anembodiment.

The Slip-on PAD of an embodiment is used (optionally) in combinationwith a perforated guide plate. FIG. 16A shows the Slip-On PAD installedover a Padgett Drum Dermatome and used with a perforated template orguide plate, under an embodiment. The perforated guide plate is placedover the target skin site and held in place with adhesive on the bottomsurface of the apron to maintain orientation. The Padgett Dermatome withSlip-On PAD is rolled over the perforated guide plate on the skin.

FIG. 16B shows skin pixel harvesting with a Padgett Drum Dermatome andinstalled Slip-On PAD, under an embodiment. For skin pixel harvesting,the Slip-On PAD is removed, adhesive tape is applied over the drum ofthe Padgett dermatome, and the clip-on blade is installed on theoutrigger arm of the dermatome, which then is used to transect the baseof the skin pixels. The Slip-on PAD of an embodiment is also used(optionally) with standard surgical instrumentation such as a ribbonretractor to protect the adjacent skin of the donor site.

Embodiments of the pixel instruments described herein include a PixelDrum Dermatome (PD2) that is a single use disposable instrument ordevice. The PD2 comprises a cylinder or rolling/rotating drum coupled toa handle, and the cylinder includes a Scalpet Drum Array. An internalblade is interlocked to the drum axle/handle assembly and/or interlockedto outriggers attached to the central axle. As with the PAD and the POSdescribed herein, small multiple pixilated resections of skin areperformed directly in the region of skin laxity, thereby enhancing skintightening with minimal visible scarring.

FIG. 17A shows an example of a Pixel Drum Dermatome being applied to atarget site of the skin surface, under an embodiment. FIG. 17B shows analternative view of a portion of the Pixel Drum Dermatome being appliedto a target site of the skin surface, under an embodiment.

The PD2 device applies a full rolling/rotating drum to the skin surfacewhere multiple small (e.g., 1.5 mm) circular incisions are created atthe target site with a “Scalpet Drum Array”. The base of each skin plugis then transected with an internal blade that is interlocked to thecentral drum axel/handle assembly and/or interlocked to outriggersattached to the central axel. Depending upon the density of the circularscalpets on the drum, a variable percentage of skin can be resected. ThePD2 enables portions (e.g., 20%, 30%, 40%, etc.) of the skin's surfacearea to be resected without visible scarring in an area of excessiveskin laxity, but the embodiment is not so limited.

Another alternative embodiment of the pixel instruments presented hereinis the Pixel Drum Harvester (PDH). Similar to the Pixel Drum Dermatome,an added internal drum harvests and aligns the pixilated resections ofskin onto an adherent membrane that is then placed over a recipient skindefect site of the patient. The conformable adherent membrane issemi-porous to allow for drainage at a recipient skin defect when themembrane with the aligned resected skin segments is extracted from thedrum and applied as a skin graft. An elastic recoil property of themembrane allows closer approximation of the pixilated skin segments,partially converting the pixilated skin graft to a sheet graft at therecipient site.

The pixel array medical systems, instruments or devices, and methodsdescribed herein evoke or enable cellular and/or extracellular responsesthat are obligatory to the clinical outcomes achieved. For the pixeldermatomes, a physical reduction of the skin surface area occurs due tothe pixilated resection of skin, i.e., creation of the skin plugs. Inaddition, a subsequent tightening of the skin results due to the delayedwound healing response. Each pixilated resection initiates an obligatewound healing sequence in multiple phases as described in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells release histamine into the “wound”.Histamine release may evoke dilatation of the capillary bed and increasevessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

The second phase (of Fibroplasia) commences within three to four days of“wounding”. During this phase, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia of the wound includes thedeposition of neocollagen and the myofibroblastic contraction of thewound.

Histologically, the deposition of neocollagen can be identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the woundsignificantly increases. The other feature of Fibroplasia is a dynamicphysical process that results in a multi-dimensional contraction of thewound. This component feature of Fibroplasia is due to the activecellular contraction of myofibroblasts. Morphologically, myoblasticcontraction of the wound will be visualized as a two dimensionaltightening of the skin surface. Overall, the effect of Fibroplasia isdermal contraction along with the deposition of a static supportingscaffolding of neocollagen with a tightened framework. The clinicaleffect is seen as a delayed tightening of skin with smoothing of skintexture over several months. The clinical endpoint is generally a moreyouthful appearing skin envelope of the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During this phase there is a strengthening and remodeling ofthe treatment area due to an increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within six totwelve months after “wounding” and may extend for at least one to twoyears. Small pixilated resections of skin should preserve the normaldermal architecture during this delayed wound healing process withoutthe creation of an evident scar that typically occurs with a largersurgical resection of skin. Lastly, there is a related stimulation andrejuvenation of the epidermis from the release of epidermal growthhormone. The delayed wound healing response can be evoked, with scarcollagen deposition, within tissues (such as muscle or fat) with minimalpre-existing collagen matrix.

Other than tightening skin for aesthetic purposes, the pixel arraymedical systems, instruments or devices, and methods described hereinmay have additional medically related applications. In some embodiments,the pixel array devices can transect a variable portion of any softtissue structure without resorting to a standard surgical resection.More specifically, the reduction of an actinic damaged area of skin viathe pixel array devices should reduce the incidence of skin cancer. Forthe treatment of sleep apnea and snoring, a pixilated mucosal reduction(soft palate, base of the tongue and lateral pharyngeal walls) via thepixel array devices would reduce the significant morbidity associatedwith more standard surgical procedures. For birth injuries of thevaginal vault, pixilated skin and vaginal mucosal resection via thepixel array devices would reestablish normal pre-partum geometry andfunction without resorting to an A&P resection. Related female stressincontinence could also be corrected in a similar fashion.

The pixel array dermatome (PAD) of an embodiment, also referred toherein as a scalpet device assembly, includes a system or kit comprisinga control device, also referred to as a punch impact hand-piece, and ascalpet device, also referred to as a tip device. The scalpet device,which is removeably coupled to the control device, includes an array ofscalpets positioned within the scalpet device. The removeable scalpetdevice of an embodiment is disposable and consequently configured foruse during a single procedure, but the embodiment is not so limited.

The PAD includes an apparatus comprising a housing configured to includea scalpet device. The scalpet device includes a substrate and a scalpetarray, and the scalpet array includes a plurality of scalpets arrangedin a configuration on the substrate. The substrate and the plurality ofscalpets are configured to be deployed from the housing and retractedinto the housing, and the plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site whendeployed. The proximal end of the control device is configured to behand-held. The housing is configured to be removeably coupled to areceiver that is a component of a control device. The control deviceincludes a proximal end that includes an actuator mechanism, and adistal end that includes the receiver. The control device is configuredto be disposable, but alternatively the control device is configured tobe at least one of cleaned, disinfected, and sterilized.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism. The scalpet device of an embodiment isconfigured so the scalpet array is deployed from the scalpet device andretracted back into the scalpet device in response to activation of theactuator mechanism. The scalpet device of an alternative embodiment isconfigured so the scalpet array is deployed from the scalpet device inresponse to activation of the actuator mechanism, and retracted backinto the scalpet device in response to release of the actuatormechanism.

FIG. 18 shows a side perspective view of the PAD assembly, under anembodiment. The PAD assembly of this embodiment includes a controldevice configured to be hand-held, with an actuator or trigger and thescalpet device comprising the scalpet array. The control device isreusable, but alternative embodiments include a disposable controldevice. The scalpet array of an embodiment is configured to create orgenerate an array of incisions (e.g., 1.5 mm, 2 mm, 3 mm, etc.) asdescribed in detail herein. The scalpet device of an embodiment includesa spring-loaded array of scalpets configured to incise the skin asdescribed in detail herein, but the embodiments are not so limited.

FIG. 19A shows a top perspective view of the scalpet device for use withthe PAD assembly, under an embodiment. FIG. 19B shows a bottomperspective view of the scalpet device for use with the PAD assembly,under an embodiment. The scalpet device comprises a housing configuredto house a substrate that is coupled to or includes a plunger. Thehousing is configured so that a proximal end of the plunger protrudesthrough a top surface of the housing. The housing is configured to beremoveably coupled to the control device, and a length of the plunger isconfigured to protrude a distance through the top surface to contact thecontrol device and actuator when the scalpet device is coupled to thecontrol device.

The substrate of the scalpet device is configured to retain numerousscalpets that form the scalpet array. The scalpet array comprises apre-specified number of scalpets as appropriate to the procedure inwhich the scalpet device assembly is used. The scalpet device includesat least one spring mechanism configured to provide a downward, orimpact or punching, force in response to activation of the scalpet arraydevice, and this force assists generation of incisions (pixelated skinresection sites) by the scalpet array. Alternatively, the springmechanism can be configured to provide an upward, or retracting, forceto assist in retraction of the scalpet array.

One or more of the scalpet device and the control device of anembodiment includes an encryption system (e.g., EPROM, etc.). Theencryption system is configured to prevent illicit use and pirating ofthe scalpet devices and/or control devices, but is not so limited.

During a procedure, the scalpet device assembly is applied one time to atarget area or, alternative, applied serially within a designated targettreatment area of skin laxity. The pixelated skin resection sites withinthe treatment area are then closed with the application of Flexansheeting, as described in detail herein, and directed closure of thesepixelated resections is performed in a direction that provides thegreatest aesthetic correction of the treatment site.

The PAD device of an alternative embodiment includes a vacuum componentor system for removing incised skin pixels. FIG. 20 shows a side view ofthe punch impact device including a vacuum component, under anembodiment. The PAD of this example includes a vacuum system orcomponent within the control device to suction evacuate the incised skinpixels, but is not so limited. The vacuum component is removeablycoupled to the PAD device, and its use is optional. The vacuum componentis coupled to and configured to generate a low-pressure zone within oradjacent to one or more of the housing, the scalpet device, the scalpetarray, and the control device. The low-pressure zone is configured toevacuate the incised skin pixels.

The PAD device of another alternative embodiment includes a radiofrequency (RF) component or system for generating skin pixels. The RFcomponent is coupled to and configured to provide or couple energywithin or adjacent to one or more of the housing, the scalpet device,the scalpet array, and the control device. The RF component isremoveably coupled to the PAD device, and its use is optional. Theenergy provided by the RF component includes one or more of thermalenergy, vibrational energy, rotational energy, and acoustic energy, toname a few.

The PAD device of yet another alternative embodiment includes a vacuumcomponent or system and an RF component or system. The PAD of thisembodiment includes a vacuum system or component within the handpiece tosuction evacuate the incised skin pixels. The vacuum component isremoveably coupled to the PAD device, and its use is optional. Thevacuum component is coupled to and configured to generate a low-pressurezone within or adjacent to one or more of the housing, the scalpetdevice, the scalpet array, and the control device. The low-pressure zoneis configured to evacuate the incised skin pixels. Additionally, the PADdevice includes an RF component coupled to and configured to provide orcouple energy within or adjacent to one or more of the housing, thescalpet device, the scalpet array, and the control device. The RFcomponent is removeably coupled to the PAD device, and its use isoptional. The energy provided by the RF component includes one or moreof thermal energy, vibrational energy, rotational energy, and acousticenergy, to name a few.

As one particular example, the PAD of an embodiment includes anelectrosurgical generator configured to more effectively incise donorskin or skin plugs with minimal thermo-conductive damage to the adjacentskin. For this reason, the RF generator operates using relatively highpower levels with relatively short duty cycles, for example. The RFgenerator is configured to supply one or more of a powered impactorcomponent configured to provide additional compressive force forcutting, cycling impactors, vibratory impactors, and an ultrasonictransducer.

The PAD with RF of this example also includes a vacuum component, asdescribed herein. The vacuum component of this embodiment is configuredto apply a vacuum that pulls the skin up towards the scalpets (e.g.,into the lumen of the scalpets, etc.) to stabilize and promote the RFmediated incision of the skin within the fractional resection field, butis not so limited. One or more of the RF generator and the vacuumappliance is coupled to be under the control of a processor running asoftware application. Additionally, the PAD of this embodiment can beused with the guide plate as described in detail herein, but is not solimited.

In addition to fractional incision at a donor site, fractional skingrafting includes the harvesting and deposition of skin plugs (e.g.,onto an adherent membrane, etc.) for transfer to a recipient site. Aswith fractional skin resection, the use of a duty-driven RF cutting edgeon an array of scalpets facilitates incising donor skin plugs. The baseof the incised scalpets is then transected and harvested as described indetail herein.

The timing of the vacuum assisted component is processor controlled toprovide a prescribed sequence with the RF duty cycle. With softwarecontrol, different variations are possible to provide the optimalsequence of combined RF cutting with vacuum assistance. Withoutlimitation, these include an initial period of vacuum prior to the RFduty cycle. Subsequent to the RF duty cycle, a period during thesequence of an embodiment includes suction evacuation of the incisedskin plugs.

Other potential control sequences of the PAD include without limitationsimultaneous duty cycles of RF and vacuum assistance. Alternatively, acontrol sequence of an embodiment includes pulsing or cycling of the RFduty cycle within the sequence and/or with variations of RF power or theuse of generators at different RF frequencies.

Another alternative control sequence includes a designated RF cycleoccurring at the depth of the fractional incision. A lower power longerduration RF duty cycle with insulated shaft with an insulated shaft anactive cutting tip could generate a thermal-conductive lesion in thedeep dermal/subcutaneous tissue interface. The deep thermal lesion wouldevoke a delayed wound healing sequence that would secondarily tightenthe skin without burning of the skin surface.

With software control, different variations are possible to provide theoptimal sequence of combined RF cutting and powered mechanical cuttingwith vacuum assistance. Examples include but are not limited tocombinations of powered mechanical cutting with vacuum assistance, RFcutting with powered mechanical cutting and vacuum assistance, RFcutting with vacuum assistance, and RF cutting with vacuum assistance.Examples of combined software controlled duty cycles include but are notlimited to precutting vacuum skin stabilization period, RF cutting dutycycle with vacuum skin stabilization period, RF cutting duty cycle withvacuum skin stabilization and powered mechanical cutting period, poweredmechanical cutting with vacuum skin stabilization period, post cuttingRF duty cycle for thermal conductive heating of the deeper dermal and/orsubdermal tissue layer to evoke a wound healing response for skintightening, and a post cutting vacuum evacuation period for skintightening.

Another embodiment of pixel array medical devices described hereinincludes a device comprising an oscillating flat array of scalpets andblade either powered electrically or deployed manually (unpowered) andused for skin tightening as an alternative to the drum/cylinderdescribed herein. FIG. 21A shows a top view of an oscillating flatscalpet array and blade device, under an embodiment. FIG. 21B shows abottom view of an oscillating flat scalpet array and blade device, underan embodiment. Blade 108 can be a fenestrated layer of blade aligned tothe scalpet array 106. The instrument handle 102 is separated from theblade handle 103 and the adherent membrane 110 can be peeled away fromthe adhesive backer 111. FIG. 21C is a close-up view of the flat arraywhen the array of scalpets 106, blades 108, adherent membrane 110 andthe adhesive backer 111 are assembled together, under an embodiment. Asassembled, the flat array of scalpets can be metered to provide auniform harvest or a uniform resection. In some embodiments, the flatarray of scalpets may further include a feeder component 115 for theadherent harvesting membrane 110 and adhesive backer 111. FIG. 21D is aclose-up view of the flat array of scalpets with a feeder component 115,under an embodiment.

In another skin grafting embodiment, the pixel graft is placed onto anirradiated cadaver dermal matrix (not shown). When cultured onto thedermal matrix, a graft of full thickness skin is created for the patientthat is immunologically identical to the pixel donor. In embodiments,the cadaver dermal matrix can also be cylindrical transected similar insize to the harvested skin pixel grafts to provide histologicalalignment of the pixilated graft into the cadaver dermal framework. FIG.22 shows a cadaver dermal matrix cylindrically transected similar insize to the harvested skin pixel grafts, under an embodiment. In someembodiments, the percentage of harvest of the donor site can bedetermined in part by the induction of a normal dermal histology at theskin defect site of the recipient, i.e., a normal (smoother) surfacetopology of the skin graft is facilitated. With either the adherentmembrane or the dermal matrix embodiment, the pixel drum harvesterincludes the ability to harvest a large surface area for grafting withvisible scarring of the patient's donor site significantly reduced oreliminated.

In addition to the pixel array medical devices described herein,embodiments include drug delivery devices. For the most part, theparenteral delivery of drugs is still accomplished from an injectionwith a syringe and needle. To circumvent the negative features of theneedle and syringe system, the topical absorption of medicationtranscutaneously through an occlusive patch was developed. However, bothof these drug delivery systems have significant drawbacks. The humanaversion to a needle injection has not abated during the nearly twocenturies of its use. The variable systemic absorption of either asubcutaneous or intramuscular drug injection reduces drug efficacy andmay increase the incidence of adverse patient responses. Depending uponthe lipid or aqueous carrier fluid of the drug, the topically appliedocclusive patch is plagued with variable absorption across an epidermalbarrier. For patients who require local anesthesia over a large surfacearea of skin, neither the syringe/needle injections nor topicalanesthetics are ideal. The syringe/needle “field” injections are oftenpainful and may instill excessive amounts of the local anesthetic thatmay cause systemic toxicity. Topical anesthetics rarely provide thelevel of anesthesia required for skin related procedures.

FIG. 23 is a drum array drug delivery device 200, under an embodiment.The drug delivery device 200 successfully addresses the limitations anddrawbacks of other drug delivery systems. The device comprises adrum/cylinder 202 supported by an axel/handle assembly 204 and rotatedaround a drum rotation component 206. The handle assembly 204 of anembodiment further includes a reservoir 208 of drugs to be delivered anda syringe plunger 210. The surface of the drum 202 is covered by anarray of needles 212 of uniform length, which provide a uniformintradermal (or subdermal) injection depth with a more controlled volumeof the drug injected into the skin of the patient. During operation, thesyringe plunger 210 pushes the drug out of the reservoir 208 to beinjected into a sealed injection chamber 214 inside the drum 202 viaconnecting tube 216. The drug is eventually delivered into the patient'sskin at a uniform depth when the array of needles 212 is pushed into apatient's skin until the surface of the drum 202 hits the skin.Non-anesthetized skip area is avoided and a more uniform pattern ofcutaneous anesthesia is created. The rolling drum application of thedrug delivery device 200 also instills the local anesthetic faster withless discomfort to the patient.

FIG. 24A is a side view of a needle array drug delivery device 300,under an embodiment. FIG. 24B is an upper isometric view of a needlearray drug delivery device 300, under an embodiment. FIG. 24C is a lowerisometric view of a needle array drug delivery device 300, under anembodiment. The drug delivery device 300 comprises a flat array of fineneedles 312 of uniform length positioned on manifold 310 can be utilizedfor drug delivery. In this example embodiment, syringe 302 in which drugfor injection is contained can be plugged into a disposable adaptor 306with handles, and a seal 308 can be utilized to ensure that the syringe302 and the disposable adaptor 306 are securely coupled to each other.When the syringe plunger 304 is pushed, drug contained in syringe 302 isdelivered from syringe 302 into the disposable adaptor 306. The drug isfurther delivered into the patient's skin through the flat array of fineneedles 312 at a uniform depth when the array of needles 312 is pushedinto a patient's skin until manifold 310 hits the skin.

The use of the drug delivery device 200 may have as many clinicalapplications as the number of pharmacological agents that requiretranscutaneous injection or absorption. For non-limiting examples, a fewof the potential applications are the injection of local anesthetics,the injection of neuromodulators such as Botulinum toxin (Botox), theinjection of insulin and the injection of replacement estrogens andcorticosteroids.

In some embodiments, the syringe plunger 210 of the drug delivery device200 can be powered by, for a non-limiting example, an electric motor. Insome embodiments, a fluid pump (not shown) attached to an IV bag andtubing can be connected to the injection chamber 214 and/or thereservoir 208 for continuous injection. In some embodiments, the volumeof the syringe plunger 210 in the drug delivery device 200 is calibratedand programmable.

Another application of pixel skin graft harvesting with the PAD (PixelArray Dermatome) device as described in detail herein is Alopecia.Alopecia is a common aesthetic malady, and it occurs most frequently inthe middle-aged male population, but is also observed in the aging babyboomer female population. The most common form of alopecia is MalePattern Baldness (MPB) that occurs in the frontal-parietal region of thescalp. Male pattern baldness is a sex-linked trait that is transferredby the X chromosome from the mother to male offspring. For men, only onegene is needed to express this phenotype. As the gene is recessive,female pattern baldness requires the transfer of both X linked genesfrom both mother and father. Phenotypic penetrance can vary from patientto patient and is most frequently expressed in the age of onset and theamount of frontal/partial/occipital alopecia. The patient variability inthe phenotypic expression of MPB is due to the variable genotypictranslation of this sex-linked trait. Based upon the genotypicoccurrence of MPB, the need for hair transplantation is vast. Othernon-genetic related etiologies are seen in a more limited segment of thepopulation. These non-genetic etiologies include trauma, fungalinfections, lupus erythematosus, radiation and chemotherapy.

A large variety of treatment options have been proposed to the public.These include FDA approved topical medications such as Minoxidil andFinasteride which have had limited success as these agents require theconversion of dormant hair follicles into an anagen growth phase. Otherremedies include hairpieces and hair weaving. The standard of practiceremains surgical hair transplantation, which involves the transfer ofhair plugs, strips and flaps from the hair-bearing scalp into the nonhair-bearing scalp. For the most part, conventional hair transplantationinvolves the transfer of multiple single hair micrographs from thehair-bearing scalp to the non hair-bearing scalp of the same patient.Alternately, the donor plugs are initially harvested as hair strips andthen secondarily sectioned into micrographs for transfer to therecipient scalp. Regardless, this multi-staged procedure is both tediousand expensive, involving several hours of surgery for the averagepatient.

The conventional hair transplantation market has been encumbered bylengthy hair grafting procedures that are performed in several stages. Atypical hair grafting procedure involves the transfer of hair plugs froma donor site in the occipital scalp to a recipient site in the baldingfrontal-parietal scalp. For most procedures, each hair plug istransferred individually to the recipient scalp. Several hundred plugsmay be transplanted during a procedure that may require several hours toperform. Post procedure “take” or viability of the transplanted hairplugs is variable due to factors that limit neovascularization at therecipient site. Bleeding and mechanical disruption due to motion are keyfactors that reduce neovascularization and “take” of hair grafts.Embodiments described herein include surgical instrumentation configuredto transfer several hair grafts at once that are secured and aligned enmasse at a recipient site on the scalp. The procedures described hereinusing the PAD of an embodiment reduce the tedium and time required withconventional instrumentation.

FIG. 25 shows the composition of human skin. Skin comprises twohorizontally stratified layers, referred to as the epidermis and thedermis, acting as a biological barrier to the external environment. Theepidermis is the enveloping layer and comprises a viable layer ofepidermal cells that migrate upward and “mature” into a nonviable layercalled the stratum corneum. The stratum corneum is a lipid-keratincomposite that serves as a primary biological barrier, and this layer iscontinually shed and reconstituted in a process called desquamation. Thedermis is the subjacent layer that is the main structural support of theskin, and is predominately extracellular and is comprised of collagenfibers.

In addition to the horizontally stratified epidermis and dermis, theskin includes vertically-aligned elements or cellular appendagesincluding the pilosebaceous units, comprising the hair folical andsebacious gland. Pilosebaceous units each include a sebaceous oil glandand a hair follicle. The sebaceous gland is the most superficial anddischarges sebum (oil) into the shaft of the hair follicle. The base ofthe hair follicle is called the bulb and the base of the bulb has a deepgenerative component called the dermal papilla. The hair follicles aretypically aligned at an oblique angle to the skin surface. Hairfollicles in a given region of the scalp are aligned parallel to eachother. Although pilosebaceous units are common throughout the entireintegument, the density and activity of these units within a region ofthe scalp is a key determinate as to the overall appearance of hair.

In additional to pilosebaceous units, sweat glands also coursevertically through the skin. They provide a water-based transudate thatassists in thermoregulation. Apocrine sweat glands in the axilla andgroin express a more pungent sweat that is responsible for body odor.For the rest of the body, eccrine sweat glands excrete a less pungentsweat for thermoregulation.

Hair follicles proceed through different physiological cycles of hairgrowth. FIG. 26 shows the physiological cycles of hair growth. Thepresence of testosterone in a genetically-prone man will producealopecia to a variable degree in the frontal-parietal scalp.Essentially, the follicle becomes dormant by entering the telogen phasewithout return to the anagen phase. Male Pattern Baldness occurs whenthe hair fails to return from the telogen phase to the anagen phase.

The PAD of an embodiment is configured for en-masse harvesting ofhair-bearing plugs with en-masse transplantation of hair bearing plugsinto non hair-bearing scalp, which truncates conventional surgicalprocedures of hair transplantation. Generally, the devices, systemsand/or methods of an embodiment are used to harvest and align a largemultiplicity of small hair bearing plugs in a single surgical step orprocess, and the same instrumentation is used to prepare the recipientsite by performing a multiple pixelated resection of non hair-bearingscalp. The multiple hair-plug graft is transferred and transplanteden-masse to the prepared recipient site. Consequently, through use of anabbreviated procedure, hundreds of hair bearing plugs can be transferredfrom a donor site to a recipient site. Hair transplantation using theembodiments described herein therefore provides a solution that is asingle surgical procedure having ease, simplicity and significant timereduction over the tedious and multiple staged conventional process.

Hair transplantation using the pixel dermatome of an embodimentfacilitates improvements in the conventional standard follicular unitextraction (FUT) hair transplant approach. Generally, under theprocedure of an embodiment hair follicles to be harvested are taken fromthe Occipital scalp of the donor. In so doing, the donor site hair ispartially shaved, and the perforated plate of an embodiment is locatedon the scalp and oriented to provide a maximum harvest. FIG. 27 showsharvesting of donor follicles, under an embodiment. The scalpets in thescalpet array are configured to penetrate down to the subcutaneous fatlater to capture the hair follicle. Once the hair plugs are incised,they are harvested onto an adhesive membrane by transecting the base ofthe hair plug with the transection blade, as described in detail herein.Original alignment of the hair plugs with respect to each other at thedonor site is maintained by applying the adherent membrane beforetransecting the base. The aligned matrix of hair plugs on the adherentmembrane will then be grafted en masse to a recipient site on thefrontal-parietal scalp of the recipient.

FIG. 28 shows preparation of the recipient site, under an embodiment.The recipient site is prepared by resection of non-hair bearing skinplugs in a topographically identical pattern as the harvested occipitalscalp donor site. The recipient site is prepared for the mass transplantof the hair plugs using the same instrumentation that was used at thedonor site under an embodiment and, in so doing, scalp defects arecreated at the recipient site. The scalp defects created at therecipient site have the same geometry as the harvested plugs on theadherent membrane.

The adherent membrane laden with the harvested hair plugs is appliedover the same pattern of scalp defects at the recipient site.Row-by-row, each hair-bearing plug is inserted into its mirror imagerecipient defect. FIG. 29 shows placement of the harvested hair plugs atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

More particularly, the donor site hair is partially shaved to preparefor location or placement of the perforated plate on the scalp. Theperforated plate is positioned on the occipital scalp donor site toprovide a maximum harvest. FIG. 30 shows placement of the perforatedplate on the occipital scalp donor site, under an embodiment. Massharvesting of hair plugs is achieved using the spring-loaded pixilationdevice comprising the impact punch hand-piece with a scalpet disposabletip. An embodiment is configured for harvesting of individual hair plugsusing off-the-shelf FUE extraction devices or biopsy punches; the holesin the perforated plates supplied are sized to accommodate off-the-shelftechnology.

The scalpets comprising the scalpet array disposable tip are configuredto penetrate down to the subcutaneous fat later to capture the hairfollicle. FIG. 31 shows scalpet penetration depth through skin when thescalpet is configured to penetrate to the subcutaneous fat layer tocapture the hair follicle, under an embodiment. Once the hair plugs areincised, they are harvested onto an adhesive membrane by transecting thebase of the hair plug with the transection blade, but are not solimited. FIG. 32 shows hair plug harvesting using the perforated plateat the occipital donor site, under an embodiment. The original alignmentof the hair plugs with respect to each other is maintained by applyingan adherent membrane of an embodiment. The adherent membrane is appliedbefore transecting the base of the resected pixels, the embodiments arenot so limited. The aligned matrix of hair plugs on the adherentmembrane is subsequently grafted en masse to a recipient site on thefrontal-parietal scalp.

Additional single hair plugs may be harvested through the perforatedplate, to be used to create the visible hairline, for example. FIG. 33shows creation of the visible hairline, under an embodiment. The visiblehairline is determined and developed with a manual FUT technique. Thevisible hairline and the mass transplant of the vertex may be performedconcurrently or as separate stages. If the visible hairline and masstransplant are performed concurrently, the recipient site is developedstarting with the visible hairline.

Transplantation of harvested hair plugs comprises preparing therecipient site is prepared by resecting non-hair bearing skin plugs in atopographically identical pattern as the pattern of the harvestedoccipital scalp donor site. FIG. 34 shows preparation of the donor siteusing the patterned perforated plate and spring-loaded pixilation deviceto create identical skin defects at the recipient site, under anembodiment. The recipient site of an embodiment is prepared for the masstransplant of the hair plugs using the same perforated plate andspring-loaded pixilation device that was used at the donor site. Scalpdefects are created at the recipient site. These scalp defects have thesame geometry as the harvested plugs on the adherent membrane.

The adherent membrane carrying the harvested hair plugs is applied overthe same pattern of scalp defects at recipient site. Row-by-row eachfollicle-bearing or hair-bearing skin plug is inserted into its mirrorimage recipient defect. FIG. 35 shows transplantation of harvested plugsby inserting harvested plugs into a corresponding skin defect created atthe recipient site, under an embodiment. Plug-to-plug alignment ismaintained, so the hair that grows from the transplanted hair plugs laysas naturally as it did at the donor site. More uniform alignment betweenthe native scalp and the transplanted hair will also occur.

Clinical endpoints vary from patient to patient, but it is predictedthat a higher percentage of hair plugs will “take” as a result ofimproved neovascularization. FIG. 36 shows a clinical end point usingthe pixel dermatome instrumentation and procedure, under an embodiment.The combination of better “takes”, shorter procedure times, and a morenatural-looking result, enable the pixel dermatome instrumentation andprocedure of an embodiment to overcome the deficiencies in conventionalhair transplant approaches.

Embodiments of pixelated skin grafting for skin defects and pixelatedskin resection for skin laxity are described in detail herein. Theseembodiments remove a field of skin pixels in an area of lax skin whereskin tightening is desired. The skin defects created by this procedure(e.g., in a range of approximately 1.5-3 mm-diameter) are small enoughto heal per primam without visible scarring; the wound closure of themultiple skin defects is performed directionally to produce a desiredcontouring effect. Live animal testing of the pixel resection procedurehas produced excellent results.

The pixel procedure of an embodiment is performed in an office settingunder a local anesthetic but is not so limited. The surgeon uses theinstrumentation of an embodiment to rapidly resect an array of skinpixels (e.g., circular, elliptical, square, etc.). Relatively littlepain is associated with the procedure. The intradermal skin defectsgenerated during the procedure are closed with the application of anadherent Flexan (3M) sheet, but embodiments are not so limited.Functioning as a large butterfly bandage, the Flexan sheet is pulled ina direction that maximizes the aesthetic contouring of the treatmentarea. A compressive elastic garment is then applied over the dressing toassist aesthetic contouring. During recovery, the patient wears asupport garment over the treatment area for a period of time (e.g., 5days, etc.). After initial healing, the multiplicity of small linearscars within the treatment area is not visibly apparent. Additional skintightening will occur subsequently over several months from the delayedwound healing response. Consequently, the pixel procedure is a minimallyinvasive alternative for skin tightening in areas where the extensivescarring of traditional aesthetic plastic surgery is to be avoided.

The pixel procedure evokes cellular and extracellular responses that areobligatory to the clinical outcomes achieved. A physical reduction ofthe skin surface area occurs due to the fractional resection of skin,which physically removes a portion of skin directly in the area oflaxity. In addition, a subsequent tightening of the skin is realizedfrom the delayed wound healing response. Each pixilated resectioninitiates an obligate wound healing sequence. The healing responseeffected in an embodiment comprises three phases, as previouslydescribed in detail herein.

The first phase of this sequence is the inflammatory phase in whichdegranulation of mast cells releases histamine into the “wound”.Histamine release evokes dilatation of the capillary bed and increasesvessel permeability into the extracellular space. This initial woundhealing response occurs within the first day and will be evident aserythema on the skin's surface.

Within days of “wounding”, the second phase of healing, fibroplasia,commences. During fibroplasia, there is migration and mitoticmultiplication of fibroblasts. Fibroplasia has two key features: thedeposition of neocollagen and the myofibroblastic contraction of thewound. Histologically, the deposition of neocollagen is identifiedmicroscopically as compaction and thickening of the dermis. Althoughthis is a static process, the tensile strength of the skin significantlyincreases. Myofibroblastic contraction is a dynamic physical processthat results in two-dimensional tightening of the skin surface. Thisprocess is due to the active cellular contraction of myofibroblasts andthe deposition of contractile proteins within the extracellular matrix.Overall, the effect of fibroplasia will be dermal contraction and thedeposition of a static supporting scaffolding of neocollagen with atightened framework. The clinical effect is realized as a delayedtightening of skin with smoothing of skin texture over some number ofmonths. The clinical endpoint is a more youthful appearing skin envelopeof the treatment area.

A third and final phase of the delayed wound healing response ismaturation. During maturation, there is a strengthening and remodelingof the treatment area due to increased cross-linkage of the collagenfibril matrix (of the dermis). This final stage commences within 6 to 12months after “wounding” and may extend for at least 1-2 years. Smallpixilated resections of skin should preserve the normal dermalarchitecture during maturation, but without the creation of a visuallyevident scar that typically occurs with a larger surgical resection ofskin. Lastly, there is a related stimulation and rejuvenation of theepidermis from the release of epidermal growth hormone.

FIGS. 37-42 show images resulting from a pixel procedure conducted on alive animal, under an embodiment. Embodiments described herein were usedin this proof-of-concept study in an animal model that verified thepixel procedure produces aesthetic skin tightening without visiblescarring. The study used a live porcine model, anesthetized for theprocedure. FIG. 37 is an image of the skin tattooed at the corners andmidpoints of the area to be resected, under an embodiment. The fieldmargins of resection were demarcated with a tattoo for post-operativeassessment, but embodiments are not so limited. The procedure wasperformed using a perforated plate (e.g., 10×10 pixel array) todesignate the area for fractional resection. The fractional resectionwas performed using biopsy punches (e.g., 1.5 mm diameter). FIG. 38 isan image of the post-operative skin resection field, under anembodiment. Following the pixel resection, the pixelated resectiondefects were closed (horizontally) with Flexan membrane.

Eleven days following the procedure, all resections had healed perprimam in the area designated by the tattoo, and photographic anddimensional measurements were made. FIG. 39 is an image at 11 daysfollowing the procedure showing resections healed per primam, withmeasured margins, under an embodiment. Photographic and dimensionalmeasurements were subsequently made 29 days following the procedure.FIG. 40 is an image at 29 days following the procedure showingresections healed per primam and maturation of the resection fieldcontinuing per primam, with measured margins, under an embodiment. FIG.41 is an image at 29 days following the procedure showing resectionshealed per primam and maturation of the resection field continuing perprimam, with measured lateral dimensions, under an embodiment.Photographic and dimensional measurements were repeated 90 dayspost-operative, and the test area skin was completely smooth to touch.FIG. 42 is an image at 90 days post-operative showing resections healedper primam and maturation of the resection field continuing per primam,with measured lateral dimensions, under an embodiment.

Embodiments include an apparatus comprising a housing configured toinclude a scalpet device. The scalpet device comprises a substrate and ascalpet array. The scalpet array includes a plurality of scalpetsarranged in a configuration on the substrate. The substrate and theplurality of scalpets is configured to be deployed from the housing andretracted into the housing. The plurality of scalpets is configured togenerate a plurality of incised skin pixels at a target site whendeployed.

Embodiments include an apparatus, comprising: a housing configured toinclude a scalpet device; and the scalpet device comprising a substrateand a scalpet array, wherein the scalpet array includes a plurality ofscalpets arranged in a configuration on the substrate, wherein thesubstrate and the plurality of scalpets is configured to be deployedfrom the housing and retracted into the housing, wherein the pluralityof scalpets is configured to generate a plurality of incised skin pixelsat a target site when deployed.

The housing is configured to be removeably coupled to a receiver.

The receiver is a component of a control device.

The control device comprises a proximal end and a distal end, whereinthe proximal end includes an actuator mechanism and the distal endincludes the receiver.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism.

The proximal end of the control device is configured to be hand-held.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device and retracted back into the scalpet device inresponse to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device in response to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is retracted backinto the scalpet device in response to release of the actuatormechanism.

The control device is configured to be disposable.

The control device is configured to be at least one of cleaned,disinfected, and sterilized.

The apparatus comprises an adherent substrate configured to capture theplurality of incised skin pixels.

The scalpet device is configured to include the adherent substrate.

The housing is configured to include the adherent substrate.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

The apparatus comprises a vacuum component.

The vacuum component is coupled to the housing.

The vacuum component is coupled to the scalpet device.

The vacuum component is coupled to the scalpet device via the housing.

The vacuum component is configured to generate a low-pressure zonewithin at least one of the scalpet device and the control device.

The low-pressure zone is configured to evacuate the plurality of incisedskin pixels.

The housing is configured to be removeably coupled to a control device,wherein the vacuum component is coupled to the control device.

The apparatus comprises a radio frequency (RF) component.

The RF component is configured to provide thermal energy to at least oneof the scalpet device and the scalpet array.

The RF component is configured to provide vibrational energy to at leastone of the scalpet device and the scalpet array.

The RF component is configured to provide rotational energy to at leastone of the scalpet device and the scalpet array.

The RF component is configured to provide acoustic energy to at leastone of the scalpet device and the scalpet array.

The RF component is coupled to the housing.

The RF component is coupled to the scalpet device.

The RF component is coupled to the scalpet device via the housing.

The RF component is coupled to the scalpet array.

The RF component is coupled to the scalpet array via the housing.

The RF component is coupled to at least one scalpet of the scalpetarray.

The RF component is coupled to the at least one scalpet of the scalpetarray via the housing.

The housing is configured to be removeably coupled to a control device,wherein the RF component is coupled to the control device.

The apparatus comprises a vacuum component coupled to at least one ofthe scalpet device and the housing, and a radio frequency (RF) componentcoupled to at least one of the scalpet device, the scalpet array, andthe housing.

The vacuum component is configured to generate a low-pressure zonewithin at least one of the scalpet device and the housing.

The RF component is configured to provide energy to at least one of thescalpet device, the scalpet array, and the housing.

The energy comprises at least one of thermal energy, vibrational energy,rotational energy, and acoustic energy.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The apparatus comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The adherent substrate is configured to apply the incised skin pixels tothe skin defects at the recipient site.

The adherent substrate is configured to align the incised skin pixelswith the skin defects at the recipient site.

The adherent substrate is configured to insert each incised skin pixelinto a corresponding skin defect at the recipient site.

The apparatus comprises at least one bandage configured for applicationat the target site.

The at least one bandage is configured to apply force to close thetarget site.

The at least one bandage is configured to apply directional force tocontrol a direction of the closure at the target site.

The at least one bandage includes a first bandage configured forapplication at the donor site.

The at least one bandage includes a second bandage configured forapplication at the recipient site.

The scalpet device is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet array is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet device is configured to be disposable.

The scalpet device is configured to be at least one of cleaned,disinfected, and sterilized.

The apparatus comprises a template configured for positioning at thetarget site.

The scalpet device is configured to align with the template.

The scalpet array is configured to align with the template.

The template is on a skin surface at the target site.

The template comprises an indicator on the skin surface at the targetsite.

The template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.

The scalpet array is removeably coupled to the scalpet device.

The scalpet array is disposable.

A shape of each scalpet of the scalpet array is elliptical.

A shape of each scalpet of the scalpet array is circular.

A shape of each scalpet of the scalpet array is semicircular.

A shape of each scalpet of the scalpet array is one of square,rectangular, and flat.

Each scalpet of the at least one scalpet includes a beveled surface.

Each scalpet of the plurality of scalpets includes at least one pointedsurface.

Each scalpet of the plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiplepoints.

The scalpet array generates the incised skin pixels using at least oneof piercing force, impact force, and rotational force.

The scalpet array generates the incised skin pixels using radiofrequency (RF) energy.

The scalpet array generates the incised skin pixels using vibrationalenergy.

At least one scalpet of the scalpet array comprises a through orifice.

At least one diametric dimension of each scalpet of the scalpet array isapproximately in a range 0.5 millimeters to 4.0 millimeters.

The apparatus comprises a guide plate configured for positioning as atemplate at the target site, wherein the guide plate includesperforations arranged in a pattern.

The scalpet array is configured to align with the perforations in theguide plate.

The scalpet array is applied to a donor site via the perforations in theguide plate, wherein the plurality of skin pixels are incised.

The scalpet array is applied to a recipient site via the perforations inthe guide plate, wherein a plurality of skin defects are generated.

The target site includes the donor site and the recipient site.

The plurality of incised skin pixels and the plurality of skin defectsare generated according to the pattern.

The apparatus comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The scalpet array is applied to the donor site directly through theperforations and the skin pixels are incised.

The scalpet array is applied to the recipient site directly through theperforations and the skin defects are generated.

The guide plate is at least one of adherent, rigid, semi-rigid,conformable, non-conformable, and non-deformable.

The guide plate includes at least one of metal, plastic, polymer, andmembranous material.

The guide plate is configured to transmit a load to a skin surface of atleast one of the donor site and the recipient site.

The guide plate is positioned directly on a skin surface at the targetsite.

The guide plate is configured to extrude the plurality of incised skinpixels.

The plurality of skin pixels is extruded through the perforations inresponse to an applied load.

The plurality of skin pixels is extruded through the incised skinsurface in response to an applied load.

The apparatus comprises a cutting member.

The incised skin pixels are transected by the cutting member.

The apparatus comprises an adherent substrate configured to capture theincised skin pixels.

The cutting member is coupled to a frame.

The frame is coupled to a guide plate, wherein the guide plate isconfigured as a guide for the scalpet device.

The adherent substrate is coupled to at least one of the frame and theguide plate.

The incised skin pixels include hair follicles.

The skin defects are configured to evoke neovascularization in theincised skin pixels inserted at the recipient site.

The skin defects are configured to evoke a wound healing response in theincised skin pixels inserted at the recipient site.

Embodiments include an apparatus, comprising: a housing including ascalpet device; and the scalpet device comprising a scalpet array thatincludes a plurality of scalpets arranged in a pattern, wherein theplurality of scalpets is deployable from the housing to generate aplurality of incised skin pixels at a target site.

Embodiments include an apparatus comprising a housing including ascalpet device. The scalpet device comprises a scalpet array thatincludes a plurality of scalpets arranged in a pattern. The plurality ofscalpets is deployable from the housing to generate a plurality ofincised skin pixels at a target site.

Embodiments include a system comprising a control device comprising aproximal end and a distal end. The proximal end includes an actuatormechanism and the distal end includes a receiver. The system includes ascalpet device configured to be removeably coupled to the receiver ofthe control device. The scalpet device includes a substrate and ascalpet array comprising a plurality of scalpets arranged in aconfiguration on the substrate. The substrate and the plurality ofscalpets are configured to be deployed in response to activation of theactuator mechanism. The plurality of scalpets is configured to generatea plurality of incised skin pixels at a target site when deployed.

Embodiments include a system comprising: a control device comprising aproximal end and a distal end, wherein the proximal end includes anactuator mechanism and the distal end includes a receiver; and a scalpetdevice configured to be removeably coupled to the receiver of thecontrol device, wherein the scalpet device includes a substrate and ascalpet array comprising a plurality of scalpets arranged in aconfiguration on the substrate, wherein the substrate and the pluralityof scalpets are configured to be deployed in response to activation ofthe actuator mechanism, wherein the plurality of scalpets is configuredto generate a plurality of incised skin pixels at a target site whendeployed.

The proximal end of the control device is configured to be hand-held.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The adherent substrate is configured to apply the incised skin pixels tothe skin defects at the recipient site.

The adherent substrate is configured to align the incised skin pixelswith the skin defects at the recipient site.

The adherent substrate is configured to insert each incised skin pixelinto a corresponding skin defect at the recipient site.

The system comprises at least one bandage configured for application atthe target site.

The at least one bandage is configured to apply force to close thetarget site.

The at least one bandage is configured to apply directional force tocontrol a direction of the closure at the target site.

The at least one bandage includes a first bandage configured forapplication at the donor site.

The at least one bandage includes a second bandage configured forapplication at the recipient site.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels.

The scalpet device is configured to include the adherent substrate.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device and retracted back into the scalpet device inresponse to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device in response to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is retracted backinto the scalpet device in response to release of the actuatormechanism.

The scalpet device is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet array is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet device is configured to be disposable.

The scalpet device is configured to be at least one of cleaned,disinfected, and sterilized.

The control device is configured to be disposable.

The control device is configured to be at least one of cleaned,disinfected, and sterilized.

The system comprises a template configured for positioning at the targetsite.

The scalpet device is configured to align with the template.

The scalpet array is configured to align with the template.

The template is on a skin surface at the target site.

The template comprises an indicator on the skin surface at the targetsite.

The template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.

The scalpet array is removeably coupled to the scalpet device.

The scalpet array is disposable.

A shape of each scalpet of the scalpet array is elliptical.

A shape of each scalpet of the scalpet array is circular.

A shape of each scalpet of the scalpet array is semicircular.

A shape of each scalpet of the scalpet array is one of square,rectangular, and flat.

Each scalpet of the at least one scalpet includes a beveled surface.

Each scalpet of the plurality of scalpets includes at least one pointedsurface.

Each scalpet of the plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiplepoints.

The scalpet array generates the incised skin pixels using at least oneof piercing force, impact force, and rotational force.

The scalpet array generates the incised skin pixels using radiofrequency (RF) energy.

The scalpet array generates the incised skin pixels using vibrationalenergy.

At least one scalpet of the scalpet array comprises a through orifice.

At least one diametric dimension of each scalpet of the scalpet array isapproximately in a range 0.5 millimeters to 4.0 millimeters.

The system comprises a vacuum component.

The vacuum component is coupled to the control device.

The vacuum component is coupled to the scalpet device.

The vacuum component is coupled to the scalpet device via the controldevice.

The vacuum component is configured to generate a low-pressure zonewithin at least one of the scalpet device and the control device.

The low-pressure zone is configured to evacuate the plurality of incisedskin pixels.

The system comprises a radio frequency (RF) component.

The RF component is configured to provide thermal energy to at least oneof the scalpet device, the scalpet array, and the control device.

The RF component is configured to provide vibrational energy to at leastone of the scalpet device, the scalpet array, and the control device.

The RF component is configured to provide rotational energy to at leastone of the scalpet device, the scalpet array, and the control device.

The RF component is configured to provide acoustic energy to at leastone of the scalpet device, the scalpet array, and the control device.

The RF component is coupled to the control device.

The RF component is coupled to the scalpet device.

The RF component is coupled to the scalpet device via the controldevice.

The RF component is coupled to the scalpet array.

The RF component is coupled to the scalpet array via the control device.

The RF component is coupled to at least one scalpet of the scalpetarray.

The RF component is coupled to the at least one scalpet of the scalpetarray via the control device.

The system comprises a vacuum component coupled to at least one of thescalpet device and the control device, and a radio frequency (RF)component coupled to at least one of the scalpet device, the scalpetarray, and the control device.

The vacuum component is configured to generate a low-pressure zonewithin at least one of the scalpet device and the control device

The RF component is configured to provide energy to at least one of thescalpet device, the scalpet array, and the control device.

The energy comprises at least one of thermal energy, vibrational energy,rotational energy, and acoustic energy.

The system comprises a guide plate configured for positioning as atemplate at the target site, wherein the guide plate includesperforations arranged in a pattern.

The scalpet array is configured to align with the perforations in theguide plate.

The scalpet array is applied to a donor site via the perforations in theguide plate, wherein the plurality of skin pixels are incised.

The scalpet array is applied to a recipient site via the perforations inthe guide plate, wherein a plurality of skin defects are generated.

The target site includes the donor site and the recipient site.

The plurality of incised skin pixels and the plurality of skin defectsare generated according to the pattern.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The scalpet array is applied to the donor site directly through theperforations and the skin pixels are incised.

The scalpet array is applied to the recipient site directly through theperforations and the skin defects are generated.

The guide plate is at least one of adherent, rigid, semi-rigid,conformable, non-conformable, and non-deformable.

The guide plate includes at least one of metal, plastic, polymer, andmembranous material.

The guide plate is configured to transmit a load to a skin surface of atleast one of the donor site and the recipient site.

The guide plate is positioned directly on a skin surface at the targetsite.

The guide plate is configured to extrude the plurality of incised skinpixels.

The plurality of skin pixels is extruded through the perforations inresponse to an applied load.

The plurality of skin pixels is extruded through the incised skinsurface in response to an applied load.

The system comprises a cutting member.

The incised skin pixels are transected by the cutting member.

An adherent substrate configured to capture the incised skin pixels.

The cutting member is coupled to a frame.

The frame is coupled to a guide plate, wherein the guide plate isconfigured as a guide for the scalpet device.

The adherent substrate is coupled to at least one of the frame and theguide plate.

The incised skin pixels include hair follicles.

The skin defects are configured to evoke neovascularization in theincised skin pixels inserted at the recipient site.

The skin defects are configured to evoke a wound healing response in theincised skin pixels inserted at the recipient site.

Embodiments include a system comprising a control device. The systemincludes a scalpet device removeably coupled to the control device. Thescalpet device includes a scalpet array comprising a plurality ofscalpets arranged in a pattern. The plurality of scalpets is configuredto deploy and retract in response to activation by the control deviceand generate a plurality of incised skin pixels at a target site.

Embodiments include a system comprising: a control device; and a scalpetdevice removeably coupled to the control device, wherein the scalpetdevice includes a scalpet array comprising a plurality of scalpetsarranged in a pattern, wherein the plurality of scalpets are configuredto deploy and retract in response to activation by the control deviceand generate a plurality of incised skin pixels at a target site.

Embodiments include a system comprising a control device comprising anactuator mechanism. The system includes a scalpet device configured tobe removeably coupled to the control device. The scalpet device includesa substrate and a scalpet array comprising a plurality of scalpetsarranged in a pattern on the substrate. The substrate and the pluralityof scalpets are configured to at least one of deploy and retract inresponse to activation of the actuator mechanism. The plurality ofscalpets is configured to generate a plurality of incised skin pixels ata target site when deployed.

Embodiments include a system comprising: a control device comprising anactuator mechanism; and a scalpet device configured to be removeablycoupled to the control device, wherein the scalpet device includes asubstrate and a scalpet array comprising a plurality of scalpetsarranged in a pattern on the substrate, wherein the substrate and theplurality of scalpets are configured to at least one of deploy andretract in response to activation of the actuator mechanism, wherein theplurality of scalpets is configured to generate a plurality of incisedskin pixels at a target site when deployed.

Embodiments include a system comprising a housing configured to includea scalpet device. The scalpet device comprises a substrate and a scalpetarray. The scalpet array includes a plurality of scalpets arranged in aconfiguration on the substrate. The substrate and the plurality ofscalpets is configured to be deployed from the housing and retractedinto the housing. The plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site when deployed. Thesystem includes a vacuum component configured to generate a low-pressurezone adjacent the scalpet device.

Embodiments include a system, comprising: a housing configured toinclude a scalpet device; the scalpet device comprising a substrate anda scalpet array, wherein the scalpet array includes a plurality ofscalpets arranged in a configuration on the substrate, wherein thesubstrate and the plurality of scalpets is configured to be deployedfrom the housing and retracted into the housing, wherein the pluralityof scalpets is configured to generate a plurality of incised skin pixelsat a target site when deployed; and a vacuum component configured togenerate a low pressure zone adjacent the scalpet device.

The vacuum component is coupled to the housing.

The vacuum component is coupled to the scalpet device.

The vacuum component is coupled to the scalpet device via the housing.

The vacuum component is configured to generate the low-pressure zonewithin the housing.

The low pressure zone is configured to evacuate the plurality of incisedskin pixels.

The housing is configured to be removeably coupled to a receiver.

The receiver is a component of a control device.

The control device comprises a proximal end and a distal end, whereinthe proximal end includes an actuator mechanism and the distal endincludes the receiver.

The scalpet array is configured to be deployed in response to activationof the actuator mechanism.

The proximal end of the control device is configured to be hand-held.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device and retracted back into the scalpet device inresponse to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is deployed fromthe scalpet device in response to activation of the actuator mechanism.

The scalpet device is configured so the scalpet array is retracted backinto the scalpet device in response to release of the actuatormechanism.

The control device is configured to be disposable.

The control device is configured to be at least one of cleaned,disinfected, and sterilized.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels.

The scalpet device is configured to include the adherent substrate.

The housing is configured to include the adherent substrate.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

The system comprises a radio frequency (RF) component.

The RF component is configured to provide thermal energy to at least oneof the scalpet device and the scalpet array.

The RF component is configured to provide vibrational energy to at leastone of the scalpet device and the scalpet array.

The RF component is configured to provide rotational energy to at leastone of the scalpet device and the scalpet array.

The RF component is configured to provide acoustic energy to at leastone of the scalpet device and the scalpet array.

The RF component is coupled to the housing.

The RF component is coupled to the scalpet device.

The RF component is coupled to the scalpet device via the housing.

The RF component is coupled to the scalpet array.

The RF component is coupled to the scalpet array via the housing.

The RF component is coupled to at least one scalpet of the scalpetarray.

The RF component is coupled to the at least one scalpet of the scalpetarray via the housing.

The housing is configured to be removeably coupled to a control device,wherein the RF component is coupled to the control device.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels IS harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The adherent substrate is configured to apply the incised skin pixels tothe skin defects at the recipient site.

The adherent substrate is configured to align the incised skin pixelswith the skin defects at the recipient site.

The adherent substrate is configured to insert each incised skin pixelinto a corresponding skin defect at the recipient site.

The system comprises at least one bandage configured for application atthe target site.

The at least one bandage is configured to apply force to close thetarget site.

The at least one bandage is configured to apply directional force tocontrol a direction of the closure at the target site.

The at least one bandage includes a first bandage configured forapplication at the donor site.

The at least one bandage includes a second bandage configured forapplication at the recipient site.

The scalpet device is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet array is configured to transfer a load to subjacent skinsurface that includes the target site, wherein the skin pixels areincised by application of the load.

The scalpet device is configured to be disposable.

The scalpet device is configured to be at least one of cleaned,disinfected, and sterilized.

The system comprises a template configured for positioning at the targetsite.

The scalpet device is configured to align with the template.

The scalpet array is configured to align with the template.

The template is on a skin surface at the target site.

The template comprises an indicator on the skin surface at the targetsite.

The template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.

The scalpet array is removeably coupled to the scalpet device.

The scalpet array is disposable.

A shape of each scalpet of the scalpet array is elliptical.

A shape of each scalpet of the scalpet array is circular.

A shape of each scalpet of the scalpet array is semicircular.

A shape of each scalpet of the scalpet array is one of square,rectangular, and flat.

Each scalpet of the at least one scalpet includes a beveled surface.

Each scalpet of the plurality of scalpets includes at least one pointedsurface.

Each scalpet of the plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiplepoints.

The scalpet array generates the incised skin pixels using at least oneof piercing force, impact force, and rotational force.

The scalpet array generates the incised skin pixels using radiofrequency (RF) energy.

The scalpet array generates the incised skin pixels using vibrationalenergy.

At least one scalpet of the scalpet array comprises a through orifice.

At least one diametric dimension of each scalpet of the scalpet array isapproximately in a range 0.5 millimeters to 4.0 millimeters.

The system comprises a guide plate configured for positioning as atemplate at the target site, wherein the guide plate includesperforations arranged in a pattern.

The scalpet array is configured to align with the perforations in theguide plate.

The scalpet array is applied to a donor site via the perforations in theguide plate, wherein the plurality of skin pixels are incised.

The scalpet array is applied to a recipient site via the perforations inthe guide plate, wherein a plurality of skin defects are generated.

The target site includes the donor site and the recipient site.

The plurality of incised skin pixels and the plurality of skin defectsare generated according to the pattern.

The system comprises an adherent substrate configured to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The adherent substrate is configured to maintain relative positioning ofthe plurality of incised skin pixels during transfer to and applicationat the recipient site.

The scalpet array is applied to the donor site directly through theperforations and the skin pixels are incised.

The scalpet array is applied to the recipient site directly through theperforations and the skin defects are generated.

The guide plate is at least one of adherent, rigid, semi-rigid,conformable, non-conformable, and non-deformable.

The guide plate includes at least one of metal, plastic, polymer, andmembranous material.

The guide plate is configured to transmit a load to a skin surface of atleast one of the donor site and the recipient site.

The guide plate is positioned directly on a skin surface at the targetsite.

The guide plate is configured to extrude the plurality of incised skinpixels.

The plurality of skin pixels is extruded through the perforations inresponse to an applied load.

The plurality of skin pixels is extruded through the incised skinsurface in response to an applied load.

The system comprises a cutting member.

The incised skin pixels are transected by the cutting member.

The system comprises an adherent substrate configured to capture theincised skin pixels.

The cutting member is coupled to a frame.

The frame is coupled to a guide plate, wherein the guide plate isconfigured as a guide for the scalpet device.

The adherent substrate is coupled to at least one of the frame and theguide plate.

The incised skin pixels include hair follicles.

The skin defects are configured to evoke neovascularization in theincised skin pixels inserted at the recipient site.

The skin defects are configured to evoke a wound healing response in theincised skin pixels inserted at the recipient site.

Embodiments include a system comprising a housing including a scalpetdevice. The scalpet device comprises a scalpet array that includes aplurality of scalpets arranged in a pattern. The plurality of scalpetsis deployable from the housing to generate a plurality of incised skinpixels at a target site. The system includes a vacuum componentconfigured to generate a low-pressure zone adjacent the scalpet device.

Embodiments include a system, comprising: a housing including a scalpetdevice; and the scalpet device comprising a scalpet array that includesa plurality of scalpets arranged in a pattern, wherein the plurality ofscalpets is deployable from the housing to generate a plurality ofincised skin pixels at a target site; and a vacuum component configuredto generate a low pressure zone adjacent the scalpet device.

Embodiments include a method comprising positioning at a target site ahousing comprising a scalpet device. The scalpet device includes asubstrate and a scalpet array. The scalpet array includes a plurality ofscalpets arranged in a configuration on the substrate. The methodincludes deploying the scalpet array from the housing into tissue at thetarget site and generating a plurality of incised skin pixels at thetarget site. The method includes retracting the scalpet array into thehousing from the target site.

Embodiments include a method comprising: positioning at a target site ahousing comprising a scalpet device, wherein the scalpet device includesa substrate and a scalpet array, wherein the scalpet array includes aplurality of scalpets arranged in a configuration on the substrate;deploying the scalpet array from the housing into tissue at the targetsite and generating a plurality of incised skin pixels at the targetsite; and retracting the scalpet array into the housing from the targetsite.

The method comprises coupling the housing to a receiver that is acomponent of a control device.

The control device comprises a proximal end and a distal end, whereinthe proximal end includes an actuator mechanism and the distal endincludes the receiver.

The deploying comprising deploying the scalpet array in response toactivation of the actuator mechanism.

The scalpet array in response to activation of the actuator mechanism.

The retracting comprises retracting the scalpet array in response torelease of the actuator mechanism.

The proximal end of the control device is configured to be hand-held.

The method comprises decoupling the scalpet device from the receiver anddisposing of the scalpet device.

The method comprises at least one of cleaning, disinfecting, andsterilizing the control device.

The method comprises capturing the plurality of incised skin pixelsusing an adherent substrate.

The scalpet device includes the adherent substrate.

The housing includes the adherent substrate.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

The method comprises harvesting the plurality of incised skin pixels.

The harvesting comprises evacuating the plurality of incised skinpixels.

The harvesting comprises generating a low-pressure zone within at leastone of the scalpet device and the housing.

The generating of the low-pressure zone comprises using a vacuumcomponent.

The vacuum component is coupled to the housing.

The vacuum component is coupled to the scalpet device.

The vacuum component is coupled to the scalpet device via the housing.

The housing is configured to be removeably coupled to a control device,wherein the vacuum component is coupled to the control device.

The generating of the plurality of incised skin pixels comprisesproviding energy to at least one of the scalpet device, the scalpetarray, and the housing.

The providing the energy comprises using a radio frequency (RF)component.

The energy comprises at least one of thermal energy, vibrational energy,rotational energy, and acoustic energy.

The providing the energy comprises providing thermal energy to at leastone of the scalpet device and the scalpet array.

The providing the energy comprises providing vibrational energy to atleast one of the scalpet device and the scalpet array.

The providing the energy comprises providing rotational energy to atleast one of the scalpet device and the scalpet array.

The providing the energy comprises providing acoustic energy to at leastone of the scalpet device and the scalpet array.

The RF component is coupled to the housing.

The RF component is coupled to the scalpet device.

The RF component is coupled to the scalpet device via the housing.

The RF component is coupled to the scalpet array.

The RF component is coupled to the scalpet array via the housing.

The RF component is coupled to at least one scalpet of the scalpetarray.

The RF component is coupled to the at least one scalpet of the scalpetarray via the housing.

The housing is configured to be removeably coupled to a control device,wherein the RF component is coupled to the control device.

The method comprises harvesting the plurality of incised skin pixelsusing a vacuum component, wherein the generating of the plurality ofincised skin pixels comprises using radio frequency (RF) energy.

The vacuum component is configured to generate a low-pressure zonewithin at least one of the scalpet device and the housing.

The RF component is configured to provide energy to at least one of thescalpet device, the scalpet array, and the housing.

The energy comprises at least one of thermal energy, vibrational energy,rotational energy, and acoustic energy.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The method comprises capturing the plurality of incised skin pixelsusing an adherent substrate and transferring the plurality of incisedskin pixels to the recipient site.

The method comprises the adherent substrate maintaining relativepositioning of the plurality of incised skin pixels during thetransferring to the recipient site.

The method comprises applying the plurality of incised skin pixels fromthe adherent substrate to the skin defects at the recipient site.

The method comprises aligning the plurality of incised skin pixels withthe skin defects at the recipient site using the adherent substrate.

The method comprises inserting each incised skin pixel from the adherentsubstrate into a corresponding skin defect at the recipient site.

The method comprises applying at least one bandage at the target site.

The applying the at least one bandage comprises applying force to closethe target site.

The applying the at least one bandage comprises applying directionalforce to control a direction of the closure at the target site.

The applying of the at least one bandage comprises applying a firstbandage at the donor site.

The applying of the at least one bandage comprises applying a secondbandage at the recipient site.

The generating the plurality of incised skin pixels comprisestransferring a load via the scalpet device to subjacent skin surfacethat includes the target site, wherein the skin pixels are incised byapplication of the load.

The generating the plurality of incised skin pixels comprisestransferring a load via the scalpet array to subjacent skin surface thatincludes the target site, wherein the skin pixels are incised byapplication of the load.

The scalpet device is configured to be disposable.

The scalpet device is configured to be at least one of cleaned,disinfected, and sterilized.

The method comprises positioning a template at the target site.

The method comprises aligning the scalpet device with the template.

The method comprises aligning the scalpet array with the template.

The positioning comprises positioning the template on a skin surface atthe target site.

The template comprises an indicator on the skin surface at the targetsite.

The template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.

The method comprises removeably coupling the scalpet array to thescalpet device.

The scalpet array is disposable.

A shape of each scalpet of the scalpet array is elliptical.

A shape of each scalpet of the scalpet array is circular.

A shape of each scalpet of the scalpet array is semicircular.

A shape of each scalpet of the scalpet array is one of square,rectangular, and flat.

Each scalpet of the plurality of scalpets includes a beveled surface.

Each scalpet of the plurality of scalpets includes at least one pointedsurface.

Each scalpet of the plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiplepoints.

The generating of the plurality of incised pixels comprises generatingusing at least one of piercing force, impact force, and rotationalforce.

The generating of the plurality of incised pixels comprises generatingusing radio frequency (RF) energy.

The generating of the plurality of incised pixels comprises generatingusing vibrational energy.

At least one scalpet of the scalpet array comprises a through orifice.

At least one diametric dimension of each scalpet of the scalpet array isapproximately in a range 0.5 millimeters to 4.0 millimeters.

The method comprises positioning a guide plate as a template at thetarget site, wherein the guide plate includes perforations arranged in apattern.

The method comprises aligning the scalpet array with the perforations inthe guide plate.

The method comprises applying the scalpet array to a donor site via theperforations in the guide plate, wherein the plurality of skin pixelsare incised.

The method comprises applying the scalpet array to a recipient site viathe perforations in the guide plate, wherein a plurality of skin defectsare generated.

The target site includes the donor site and the recipient site.

The method comprises generating the plurality of incised skin pixels andthe plurality of skin defects according to the pattern.

The method comprises capturing with an adherent substrate the pluralityof incised skin pixels at the donor site and transferring the pluralityof incised skin pixels to the recipient site.

The method comprises maintaining with the adherent substrate relativepositioning of the plurality of incised skin pixels during transferringto and application at the recipient site.

The method comprises applying the scalpet array to the donor sitedirectly through the perforations and the skin pixels are incised.

The method comprises applying the scalpet array to the recipient sitedirectly through the perforations and the skin defects are generated.

The guide plate is at least one of adherent, rigid, semi-rigid,conformable, non-conformable, and non-deformable.

The guide plate includes at least one of metal, plastic, polymer, andmembranous material.

The guide plate is configured to transmit a load to a skin surface of atleast one of the donor site and the recipient site.

The method comprises positioning the guide plate directly on a skinsurface at the target site.

The method comprises extruding the plurality of incised skin pixelsusing the guide plate.

The method comprises extruding the plurality of skin pixels through theperforations in response to an applied load.

The method comprises extruding the plurality of skin pixels through theincised skin surface in response to an applied load.

The generating of the plurality of incised skin pixels comprisesincising with a cutting member.

The method comprises transecting the incised skin pixels with thecutting member.

The method comprises capturing the incised skin pixels with an adherentsubstrate.

The cutting member is coupled to a frame.

The frame is coupled to a guide plate, wherein the guide plate isconfigured as a guide for the scalpet device.

The adherent substrate is coupled to at least one of the frame and theguide plate.

The incised skin pixels include hair follicles.

The method comprises using the skin defects to evoke neovascularizationin the incised skin pixels inserted at the recipient site

The method comprises using the skin defects to evoke a wound healingresponse in the incised skin pixels inserted at the recipient site.

Embodiments include a method comprising: forming a coupling between acontrol device and a scalpet device, wherein the control device includesan actuator, wherein the scalpet device includes a scalpet arraycomprising a plurality of scalpets arranged in a pattern; aligning thescalpet device at a target site; and generating a plurality of incisedskin pixels and a plurality of skin defects by deploying the scalpetarray into tissue at the target site, wherein the scalpet array isdeployed in response to activation of the actuator.

Embodiments include a method comprising: forming a coupling between acontrol device and a scalpet device, wherein the control device includesan actuator, wherein the scalpet device includes a scalpet arraycomprising a plurality of scalpets arranged in a pattern; aligning thescalpet device at a target site; and generating a plurality of incisedskin pixels and a plurality of skin defects by deploying the scalpetarray into tissue at the target site, wherein the scalpet array isdeployed in response to activation of the actuator.

Embodiments include a method comprising: positioning a housing at atarget site, wherein the housing includes a scalpet array comprising aplurality of scalpets arranged in a pattern; deploying the scalpet arrayinto tissue at the target site; generating a plurality of incised skinpixels at the target site when the target site is a donor site;generating a plurality of skin defects at the target site when thetarget site is a recipient site; and harvesting the plurality of incisedskin pixels.

Embodiments include a method comprising: positioning a housing at atarget site, wherein the housing includes a scalpet array comprising aplurality of scalpets arranged in a pattern; deploying the scalpet arrayinto tissue at the target site; generating a plurality of incised skinpixels at the target site when the target site is a donor site;generating a plurality of skin defects at the target site when thetarget site is a recipient site; and harvesting the plurality of incisedskin pixels.

Embodiments include a method comprising: positioning a housing at adonor site, wherein the housing includes a scalpet array comprising aplurality of scalpets arranged in a pattern; deploying the scalpet arrayinto tissue at the donor site and generating a plurality of incised skinpixels; capturing the plurality of incised skin pixels at the donor siteand transferring the incised skin pixels to a recipient; positioning thehousing at the recipient site, and deploying the scalpet array intotissue at the recipient site and generating a plurality of skin defects;and applying the plurality of incised skin pixels to the skin defects atthe recipient site.

Embodiments include a method comprising: positioning a housing at adonor site, wherein the housing includes a scalpet array comprising aplurality of scalpets arranged in a pattern; deploying the scalpet arrayinto tissue at the donor site and generating a plurality of incised skinpixels; capturing the plurality of incised skin pixels at the donor siteand transferring the incised skin pixels to a recipient; positioning thehousing at the recipient site, and deploying the scalpet array intotissue at the recipient site and generating a plurality of skin defects;and applying the plurality of incised skin pixels to the skin defects atthe recipient site.

Embodiments include a method comprising: configuring a housing toinclude a scalpet device; and configuring the scalpet device to includea substrate and a scalpet array, wherein the scalpet array is configuredto include a plurality of scalpets arranged in a configuration on thesubstrate, wherein the substrate and the plurality of scalpets isconfigured to be deployed from the housing and retracted into thehousing, wherein the plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site when deployed.

Embodiments include a method comprising: configuring a housing toinclude a scalpet device; and configuring the scalpet device to includea substrate and a scalpet array, wherein the scalpet array is configuredto include a plurality of scalpets arranged in a configuration on thesubstrate, wherein the substrate and the plurality of scalpets isconfigured to be deployed from the housing and retracted into thehousing, wherein the plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site when deployed.

The method comprises configuring the housing to be removeably coupled toa receiver.

The receiver is a component of a control device.

The method comprises configuring the control device to include aproximal end and a distal end, wherein the proximal end includes anactuator mechanism and the distal end includes the receiver.

The method comprises configuring the scalpet array to be deployed inresponse to activation of the actuator mechanism.

The method comprises configuring the proximal end of the control deviceto be hand-held.

The method comprises configuring the scalpet device so the scalpet arrayis deployed from the scalpet device and retracted back into the scalpetdevice in response to activation of the actuator mechanism.

The method comprises configuring the scalpet device so the scalpet arrayis deployed from the scalpet device in response to activation of theactuator mechanism.

The method comprises configuring the scalpet device so the scalpet arrayis retracted back into the scalpet device in response to release of theactuator mechanism.

The method comprises configuring the control device to be disposable.

The method comprises configuring the control device to be at least oneof cleaned, disinfected, and sterilized.

The method comprises configuring an adherent substrate to capture theplurality of incised skin pixels.

The method comprises configuring the scalpet device to include theadherent substrate.

The method comprises configuring the housing to include the adherentsubstrate.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

The method comprises configuring at least one of the housing, thescalpet device, and the scalpet array for use with a vacuum component.

The method comprises configuring the housing for coupling to the vacuumcomponent.

The method comprises configuring the scalpet device for coupling to thevacuum component for coupling to the scalpet device.

The method comprises configuring the scalpet device for coupling to thevacuum component via the housing.

The method comprises configuring at least one of the scalpet device andthe control device to include a low-pressure zone.

The method comprises configuring the low-pressure zone to evacuate theplurality of incised skin pixels.

The method comprises configuring the housing to be removeably coupled toa control device, wherein the vacuum component is coupled to the controldevice.

The method comprises configuring at least one of the housing, thescalpet device, and the scalpet array for use with a radio frequency(RF) component.

The method comprises configuring the RF component to provide thermalenergy to at least one of the scalpet device and the scalpet array.

The method comprises configuring the RF component to provide vibrationalenergy to at least one of the scalpet device and the scalpet array.

The method comprises configuring the RF component to provide rotationalenergy to at least one of the scalpet device and the scalpet array.

The method comprises configuring the RF component to provide acousticenergy to at least one of the scalpet device and the scalpet array.

The method comprises coupling the RF component to the housing.

The method comprises coupling the RF component to the scalpet device.

The method comprises coupling the RF component to the scalpet device viathe housing.

The method comprises coupling the RF component to the scalpet array.

The method comprises coupling the RF component to the scalpet array viathe housing.

The method comprises coupling the RF component to at least one scalpetof the scalpet array.

The method comprises coupling the RF component to the at least onescalpet of the scalpet array via the housing.

The method comprises configuring the housing to be removeably coupled toa control device, wherein the RF component is coupled to the controldevice.

The method comprises coupling a vacuum component at least one of thescalpet device and the housing, and coupling a radio frequency (RF)component at least one of the scalpet device, the scalpet array, and thehousing.

The method comprises configuring at least one of the scalpet device andthe housing to include a low-pressure zone.

The method comprises configuring at least one of the scalpet device, thescalpet array, and the housing to receive energy from the RF component.

The energy comprises at least one of thermal energy, vibrational energy,rotational energy, and acoustic energy.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The target site includes a donor site, wherein the plurality of incisedskin pixels is harvested at the donor site.

The target site includes a recipient site, wherein the incised skinpixels generate skin defects at the recipient site.

The method comprises configuring an adherent substrate to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The method comprises configuring the adherent substrate to maintainrelative positioning of the plurality of incised skin pixels duringtransfer to and application at the recipient site.

The method comprises configuring the adherent substrate to apply theincised skin pixels to the skin defects at the recipient site.

The method comprises configuring the adherent substrate to align theincised skin pixels with the skin defects at the recipient site.

The method comprises configuring the adherent substrate to insert eachincised skin pixel into a corresponding skin defect at the recipientsite.

The method comprises configuring at least one bandage for application atthe target site.

The method comprises configuring the at least one bandage to apply forceto close the target site.

The method comprises configuring the at least one bandage to applydirectional force to control a direction of the closure at the targetsite.

The at least one bandage includes a first bandage configured forapplication at the donor site.

The at least one bandage includes a second bandage configured forapplication at the recipient site.

The method comprises configuring the scalpet device to transfer a loadto subjacent skin surface that includes the target site, wherein theskin pixels are incised by application of the load.

The method comprises configuring the scalpet array to transfer a load tosubjacent skin surface that includes the target site, wherein the skinpixels are incised by application of the load.

The method comprises configuring the scalpet device to be disposable.

The method comprises configuring the scalpet device to be at least oneof cleaned, disinfected, and sterilized.

The method comprises configuring a template for positioning at thetarget site.

The method comprises configuring the scalpet device to align with thetemplate.

The method comprises configuring the scalpet array to align with thetemplate.

The template is on a skin surface at the target site.

The template comprises an indicator on the skin surface at the targetsite.

The template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.

The scalpet array is removeably coupled to the scalpet device.

The scalpet array is disposable.

A shape of each scalpet of the scalpet array is elliptical.

A shape of each scalpet of the scalpet array is circular.

A shape of each scalpet of the scalpet array is semicircular.

A shape of each scalpet of the scalpet array is one of square,rectangular, and flat.

Each scalpet of the at least one scalpet includes a beveled surface.

Each scalpet of the plurality of scalpets includes at least one pointedsurface.

Each scalpet of the plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiplepoints.

The method comprises configuring the scalpet array to generate theincised skin pixels using at least one of piercing force, impact force,and rotational force.

The method comprises configuring the scalpet array to generate theincised skin pixels using radio frequency (RF) energy.

The method comprises configuring the scalpet array to generate theincised skin pixels using vibrational energy.

At least one scalpet of the scalpet array comprises a through orifice.

At least one diametric dimension of each scalpet of the scalpet array isapproximately in a range 0.5 millimeters to 4.0 millimeters.

The method comprises configuring a guide plate for positioning as atemplate at the target site, wherein the guide plate includesperforations arranged in a pattern.

The method comprises configuring the scalpet array to align with theperforations in the guide plate.

The method comprises configuring the scalpet array to be applied to adonor site via the perforations in the guide plate, wherein theplurality of skin pixels are incised.

The method comprises configuring the scalpet array to be applied to arecipient site via the perforations in the guide plate, wherein aplurality of skin defects are generated.

The target site includes the donor site and the recipient site.

The plurality of incised skin pixels and the plurality of skin defectsare generated according to the pattern.

The method comprises configuring an adherent substrate to capture theplurality of incised skin pixels at the donor site and transfer theplurality of incised skin pixels to the recipient site.

The method comprises configuring the adherent substrate to maintainrelative positioning of the plurality of incised skin pixels duringtransfer to and application at the recipient site.

The method comprises configuring the scalpet array to be applied to thedonor site directly through the perforations to incise the skin pixels.

The method comprises configuring the scalpet array to be applied to therecipient site directly through the perforations to generate the skindefects.

The method comprises configuring the guide plate to be at least one ofadherent, rigid, semi-rigid, conformable, non-conformable, andnon-deformable.

The method comprises configuring the guide plate to include at least oneof metal, plastic, polymer, and membranous material.

The method comprises configuring the guide plate to transmit a load to askin surface of at least one of the donor site and the recipient site.

The method comprises configuring the guide plate to be positioneddirectly on a skin surface at the target site.

The method comprises configuring the guide plate to extrude theplurality of incised skin pixels.

The plurality of skin pixels is extruded through the perforations inresponse to an applied load.

The plurality of skin pixels is extruded through the incised skinsurface in response to an applied load.

The method comprises configuring at least one of the housing, thescalpet device, and the scalpet array for use with a cutting member.

The incised skin pixels are transected by the cutting member.

The method comprises configuring an adherent substrate to capture theincised skin pixels.

The method comprises configuring the cutting member to be coupled to aframe.

The frame is coupled to a guide plate, wherein the guide plate isconfigured as a guide for the scalpet device.

The method comprises configuring the adherent substrate to be coupled toat least one of the frame and the guide plate.

The incised skin pixels include hair follicles.

The method comprises configuring the skin defects to evokeneovascularization in the incised skin pixels inserted at the recipientsite.

The method comprises configuring the skin defects to evoke a woundhealing response in the incised skin pixels inserted at the recipientsite.

Embodiments include a method comprising configuring a housing to includea scalpet device. The method includes configuring the scalpet device toinclude a scalpet array comprising a plurality of scalpets arranged in apattern. The plurality of scalpets is configured to be deployed from thehousing and generate a plurality of incised skin pixels at a targetsite.

Embodiments include a method comprising: configuring a housing toinclude a scalpet device; and configuring the scalpet device to includea scalpet array comprising a plurality of scalpets arranged in apattern, wherein the plurality of scalpets is configured to be deployedfrom the housing and generate a plurality of incised skin pixels at atarget site.

Embodiments include a method comprising configuring a control device toinclude a proximal end and a distal end. The proximal end includes anactuator. The method includes configuring a housing to include a scalpetdevice and for removeable coupling to the distal end of the controldevice. The method includes configuring the scalpet device to include ascalpet array comprising a plurality of scalpets arranged in a pattern.The plurality of scalpets is configured to be deployed from the housingto generate a plurality of incised skin pixels at a target site whendeployed.

Embodiments include a method comprising: configuring a control device toinclude a proximal end and a distal end, wherein the proximal endincludes an actuator; configuring a housing to include a scalpet deviceand for removeable coupling to the distal end of the control device; andconfiguring the scalpet device to include a scalpet array comprising aplurality of scalpets arranged in a pattern, wherein the plurality ofscalpets is configured to be deployed from the housing to generate aplurality of incised skin pixels at a target site when deployed.

Unless the context clearly requires otherwise, throughout thedescription, the words “comprise,” “comprising,” and the like are to beconstrued in an inclusive sense as opposed to an exclusive or exhaustivesense; that is to say, in a sense of “including, but not limited to.”Words using the singular or plural number also include the plural orsingular number respectively. Additionally, the words “herein,”“hereunder,” “above,” “below,” and words of similar import, when used inthis application, refer to this application as a whole and not to anyparticular portions of this application. When the word “or” is used inreference to a list of two or more items, that word covers all of thefollowing interpretations of the word: any of the items in the list, allof the items in the list and any combination of the items in the list.

The above description of embodiments is not intended to be exhaustive orto limit the systems and methods to the precise forms disclosed. Whilespecific embodiments of, and examples for, the medical devices andmethods are described herein for illustrative purposes, variousequivalent modifications are possible within the scope of the systemsand methods, as those skilled in the relevant art will recognize. Theteachings of the medical devices and methods provided herein can beapplied to other systems and methods, not only for the systems andmethods described above.

The elements and acts of the various embodiments described above can becombined to provide further embodiments. These and other changes can bemade to the medical devices and methods in light of the above detaileddescription.

In general, in the following claims, the terms used should not beconstrued to limit the medical devices and methods and correspondingsystems and methods to the specific embodiments disclosed in thespecification and the claims, but should be construed to include allsystems that operate under the claims. Accordingly, the medical devicesand methods and corresponding systems and methods are not limited by thedisclosure, but instead the scope is to be determined entirely by theclaims.

While certain aspects of the medical devices and methods andcorresponding systems and methods are presented below in certain claimforms, the inventors contemplate the various aspects of the medicaldevices and methods and corresponding systems and methods in any numberof claim forms. Accordingly, the inventors reserve the right to addadditional claims after filing the application to pursue such additionalclaim forms for other aspects of the medical devices and methods andcorresponding systems and methods.

What is claimed is:
 1. A system comprising: a control device comprisinga proximal end and a distal end, wherein the proximal end includes anactuator mechanism and the distal end includes a receiver; and a scalpetdevice configured to be re moveably coupled to the receiver of thecontrol device, wherein the scalpet device includes a substrate and ascalpet array comprising a plurality of scalpets arranged in aconfiguration on the substrate, wherein a shape of each scalpet iscircular, wherein the substrate and the plurality of scalpets areconfigured to be deployed in response to activation of the actuatormechanism, wherein the plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site when deployed; and avacuum component.
 2. The system of claim 1, wherein the proximal end ofthe control device is configured to be hand-held.
 3. The system of claim1, wherein the target site includes a donor site, wherein the pluralityof incised skin pixels are harvested at the donor site.
 4. The system ofclaim 3, wherein the target site includes a recipient site, wherein theincised skin pixels generate skin defects at the recipient site.
 5. Thesystem of claim 4, comprising an adherent substrate configured tocapture the plurality of incised skin pixels at the donor site andtransfer the plurality of incised skin pixels to the recipient site. 6.The system of claim 5, wherein the adherent substrate is configured tomaintain relative positioning of the plurality of incised skin pixelsduring transfer to and application at the recipient site.
 7. The systemof claim 5, wherein the adherent substrate is configured to apply theincised skin pixels to the skin defects at the recipient site.
 8. Thesystem of claim 5, wherein the adherent substrate is configured to alignthe incised skin pixels with the skin defects at the recipient site. 9.The system of claim 8, wherein the adherent substrate is configured toinsert each incised skin pixel into a corresponding skin defect at therecipient site.
 10. The system of claim 4, comprising at least onebandage configured for application at the target site.
 11. The system ofclaim 10, wherein the at least one bandage is configured to apply forceto close the target site.
 12. The system of claim 10, wherein the atleast one bandage is configured to apply directional force to control adirection of the closure at the target site.
 13. The system of claim 12,wherein the at least one bandage includes a first bandage configured forapplication at the donor site.
 14. The system of claim 12, wherein theat least one bandage includes a second bandage configured forapplication at the recipient site.
 15. The system of claim 1, comprisingan adherent substrate configured to capture the plurality of incisedskin pixels.
 16. The system of claim 15, wherein the adherent substratecomprises a flexible substrate.
 17. The system of claim 15, wherein theadherent substrate comprises a semi-porous membrane.
 18. The system ofclaim 1, wherein the scalpet device is configured so the scalpet arrayis deployed from the scalpet device and retracted back into the scalpetdevice in response to activation of the actuator mechanism.
 19. Thesystem of claim 1, wherein the scalpet device is configured so thescalpet array is deployed from the scalpet device in response toactivation of the actuator mechanism.
 20. The system of claim 19,wherein the scalpet device is configured so the scalpet array isretracted back into the scalpet device in response to release of theactuator mechanism.
 21. The system of claim 1, wherein the scalpetdevice is configured to transfer a load to subjacent skin surface thatincludes the target site, wherein the skin pixels are incised byapplication of the load.
 22. The system of claim 1, wherein the scalpetarray is configured to transfer a load to subjacent skin surface thatincludes the target site, wherein the skin pixels are incised byapplication of the load.
 23. The system of claim 1, wherein the scalpetdevice is configured to be disposable.
 24. The system of claim 1,wherein the scalpet device is configured to be at least one of cleaned,disinfected, and sterilized.
 25. The system of claim 1, wherein thecontrol device is configured to be disposable.
 26. The system of claim1, wherein the control device is configured to be at least one ofcleaned, disinfected, and sterilized.
 27. The system of claim 1,comprising a template configured for positioning at the target site. 28.The system of claim 27, wherein the scalpet device is configured toalign with the template.
 29. The system of claim 27, wherein the scalpetarray is configured to align with the template.
 30. The system of claim27, wherein the template is on a skin surface at the target site. 31.The system of claim 30, wherein the template comprises an indicator onthe skin surface at the target site.
 32. The system of claim 30, whereinthe template includes a guide plate configured for positioning at thetarget site and comprising perforations arranged in a pattern.
 33. Thesystem of claim 1, wherein the scalpet array is removeably coupled tothe scalpet device.
 34. The system of claim 1, wherein the scalpet arrayis disposable.
 35. The system of claim 1, wherein each scalpet of the atleast one scalpet includes a beveled surface.
 36. The system of claim 1,wherein each scalpet of the plurality of scalpets includes at least onepointed surface.
 37. The system of claim 1, wherein each scalpet of theplurality of scalpets includes at least one needle.
 38. The system ofclaim 37, wherein the at least one needle comprises at least one needleincluding multiple points.
 39. The system of claim 1, wherein thescalpet array generates the incised skin pixels using at least one ofpiercing force, impact force, and rotational force.
 40. The system ofclaim 1, wherein the scalpet array generates the incised skin pixelsusing radio frequency (RF) energy.
 41. The system of claim 1, whereinthe scalpet array generates the incised skin pixels using vibrationalenergy.
 42. The system of claim 1, wherein at least one scalpet of thescalpet array comprises a through orifice.
 43. The system of claim 1,wherein at least one diametric dimension of each scalpet of the scalpetarray is approximately in a range 0.5 millimeters to 4.0 millimeters.44. The system of claim 1, wherein the vacuum component is coupled tothe control device.
 45. The system of claim 1, wherein the vacuumcomponent is coupled to the scalpet device.
 46. The system of claim 1,wherein the vacuum component is coupled to the scalpet device via thecontrol device.
 47. The system of claim 1, wherein the vacuum componentis configured to generate a low pressure zone within at least one of thescalpet device and the control device.
 48. The system of claim 47,wherein the low pressure zone is configured to evacuate the plurality ofincised skin pixels.
 49. The system of claim 1, comprising a radiofrequency (RF) component.
 50. The system of claim 49, wherein the RFcomponent is configured to provide thermal energy to at least one of thescalpet device, the scalpet array, and the control device.
 51. Thesystem of claim 49, wherein the RF component is configured to providevibrational energy to at least one of the scalpet device, the scalpetarray, and the control device.
 52. The system of claim 49, wherein theRF component is configured to provide rotational energy to at least oneof the scalpet device, the scalpet array, and the control device. 53.The system of claim 49, wherein the RF component is configured toprovide acoustic energy to at least one of the scalpet device, thescalpet array, and the control device.
 54. The system of claim 49,wherein the RF component is coupled to the control device.
 55. Thesystem of claim 49, wherein the RF component is coupled to the scalpetdevice.
 56. The system of claim 49, wherein the RF component is coupledto the scalpet device via the control device.
 57. The system of claim49, wherein the RF component is coupled to the scalpet array.
 58. Thesystem of claim 49, wherein the RF component is coupled to the scalpetarray via the control device.
 59. The system of claim 49, wherein the RFcomponent is coupled to at least one scalpet of the scalpet array. 60.The system of claim 49, wherein the RF component is coupled to the atleast one scalpet of the scalpet array via the control device.
 61. Thesystem of claim 1, comprising: a radio frequency (RF) component coupledto at least one of the scalpet device, the scalpet array, and thecontrol device.
 62. The system of claim 61, wherein the vacuum componentis configured to generate a low pressure zone within at least one of thescalpet device and the control device.
 63. The system of claim 61,wherein the RF component is configured to provide energy to at least oneof the scalpet device, the scalpet array, and the control device. 64.The system of claim 63, wherein the energy comprises at least one ofthermal energy, vibrational energy, rotational energy, and acousticenergy.
 65. The system of claim 1, comprising a guide plate configuredfor positioning as a template at the target site, wherein the guideplate includes perforations arranged in a pattern.
 66. The system ofclaim 65, wherein the scalpet array is configured to align with theperforations in the guide plate.
 67. The system of claim 65, wherein thescalpet array is applied to a donor site via the perforations in theguide plate, wherein the plurality of skin pixels are incised.
 68. Thesystem of claim 67, wherein the scalpet array is applied to a recipientsite via the perforations in the guide plate, wherein a plurality ofskin defects are generated.
 69. The system of claim 68, wherein thetarget site includes the donor site and the recipient site.
 70. Thesystem of claim 68, wherein the plurality of incised skin pixels and theplurality of skin defects are generated according to the pattern. 71.The system of claim 68, comprising an adherent substrate configured tocapture the plurality of incised skin pixels at the donor site andtransfer the plurality of incised skin pixels to the recipient site. 72.The system of claim 71, wherein the adherent substrate is configured tomaintain relative positioning of the plurality of incised skin pixelsduring transfer to and application at the recipient site.
 73. The systemof claim 68, wherein the scalpet array is applied to the donor sitedirectly through the perforations and the skin pixels are incised. 74.The system of claim 68, wherein the scalpet array is applied to therecipient site directly through the perforations and the skin defectsare generated.
 75. The system of claim 65, wherein the guide plate is atleast one of adherent, rigid, semi-rigid, conformable, non-conformable,and non-deformable.
 76. The system of claim 65, wherein the guide plateincludes at least one of metal, plastic, polymer, and membranousmaterial.
 77. The system of claim 65, wherein the guide plate isconfigured to transmit a load to a skin surface of at least one of thedonor site and the recipient site.
 78. The system of claim 65, whereinthe guide plate is positioned directly on a skin surface at the targetsite.
 79. The system of claim 78, wherein the guide plate is configuredto extrude the plurality of incised skin pixels.
 80. The system of claim79, wherein the plurality of skin pixels are extruded through theperforations in response to an applied load.
 81. The system of claim 79,wherein the plurality of skin pixels are extruded through the incisedskin surface in response to an applied load.
 82. The system of claim 1,comprising a cutting member.
 83. The system of claim 82, wherein theincised skin pixels are transected by the cutting member.
 84. The systemof claim 83, comprising an adherent substrate configured to capture theincised skin pixels.
 85. The system of claim 84, wherein the cuttingmember is coupled to a frame.
 86. The system of claim 85, wherein theframe is coupled to a guide plate, wherein the guide plate is configuredas a guide for the scalpet device.
 87. The system of claim 85, whereinthe adherent substrate is coupled to at least one of the frame and theguide plate.
 88. The system of claim 1, wherein the incised skin pixelsinclude hair follicles.
 89. The system of claim 1, wherein the skindefects are configured to evoke neovascularization in the incised skinpixels inserted at the recipient site.
 90. The system of claim 1,wherein the skin defects are configured to evoke a wound healingresponse in the incised skin pixels inserted at the recipient site. 91.A system comprising: a control device comprising an actuator mechanism;and a scalpet device configured to be removeably coupled to the controldevice, wherein the scalpet device includes a substrate and a scalpetarray comprising a plurality of scalpets arranged in a pattern on thesubstrate, wherein a shape of each scalpet is circular, wherein thesubstrate and the plurality of scalpets are configured to at least oneof deploy and retract in response to activation of the actuatormechanism, wherein the plurality of scalpets is configured to generate aplurality of incised skin pixels at a target site when deployed.